nitinol and Esophageal-Stenosis

Esophageal cancer is a very deadly disease, killing more than 15,000 people in the United States annually. Almost 400,000 new cases happen in the worldwide every year. More than 50% esophageal cancer patients are diagnosed at an advanced stage when they need an esophageal stent to open the blocked esophagus for feeding and drinking. Esophageal stents have evolved in stages over the years. Current clinically used stents commonly include stainless steel or nitinol self-expandable metallic stent (SEMS) and self-expandable plastic stent (SEPS). There are many choices of different types of stents and sizes, with fierce competition among manufacturers. However, current stent technology, whether uncovered, partially covered, fully covered SEMS or SEPS, has their own advantages to solve the dysphagia, stricture, and fistula problems, but they also cause some clinical complications. The ideal stent remains elusive. New 3D printing technique may bring new promising potential to manufacturing personalized esophageal stents. Drug-eluting stents could be the new avenue to do more than just pry open a stricture or cover a defect in the esophageal lumen, a possibility of proving local anticancer therapy simultaneously. Additionally, the lack of esophageal cancer animal models also hinders the progress of stent development. This paper reviews these topics for a comprehensive understanding of this field. In a conclusion, the ultimate goal of the future esophageal stent would have multifunction to treat the underlying conditions and restore esophageal function to near normal.

Topics: Alloys; Animals; Constriction, Pathologic; Deglutition Disorders; Drug-Eluting Stents; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagus; Fistula; Humans; Models, Animal; Palliative Care; Plastics; Printing, Three-Dimensional; Stainless Steel; Stents

To investigate the efficacy of double-layered covered stent in the treatment of malignant oesophageal obstructions.. A systematic review and meta-analysis was performed following the PRISMA process. PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus and online content, were searched for studies reporting on the NiTi-S polyurethane-covered double oesophageal stent for the treatment of malignant dysphagia. Weighted pooled outcomes were synthesized with a random effects model to account for clinical heterogeneity. All studies reporting the outcome of palliative management of dysphagia due to histologically confirmed malignant oesophageal obstruction using double-layered covered nitinol stent were included. The level of statistical significance was set at α = 0.05.. Six clinical studies comprising 250 patients in total were identified. Pooled technical success of stent insertion was 97.2% (95%CI: 94.8%-98.9%; I (2) = 5.8%). Pooled complication rate was 27.6% (95%CI: 20.7%-35.2%; I (2) = 41.9%). Weighted improvement of dysphagia on a scale of 0-5 scoring system was -2.00 [95%CI: -2.29%-(-1.72%); I (2) = 87%]. Distal stent migration was documented in 10 out of the 250 cases examined. Pooled stent migration rate was 4.7% (95%CI: 2.5%-7.7%; I (2) = 0%). Finally, tumour overgrowth was reported in 34 out of the 250 cases with pooled rate of tumour overgrowth of 11.2% (95%CI: 3.7%-22.1%; I (2) = 82.2%). No funnel plot asymmetry to suggest publication bias (bias = 0.39, P = 0.78). In the sensitivity analysis all results were largely similar between the fixed and random effects models.. The double-layered nitinol stent provides immediate relief of malignant dysphagia with low rates of stent migration and tumour overgrowth.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Neoplasm Recurrence, Local; Statistics as Topic; Stents; Treatment Outcome

Endoscopic esophageal stent placement is widely used in the treatment of a variety of benign and malignant esophageal conditions. Self expanding metal stents (SEMS) are associated with significantly reduced stent related mortality and morbidity compared to plastic stents for treatment of esophageal conditions; however they have known complications of stent migration, stent occlusion, tumor ingrowth, stricture formation, reflux, bleeding and perforation amongst others. A rare and infrequently reported complication of SEMS is stent fracture and subsequent migration of the broken pieces. There have only been a handful of published case reports describing this problem. In this report we describe a case of a spontaneously fractured nitinol esophageal SEMS, and review the available literature on the unusual occurrence of SEMS fracture placed for benign or malignant obstruction in the esophagus. SEMS fracture could be a potentially dangerous event and should be considered in a patient having recurrent dysphagia despite successful placement of an esophageal SEMS. It usually requires endoscopic therapy and may unfortunately require surgery for retrieval of a distally migrated fragment. Early recognition and prompt management may be able to prevent further problems.

Topics: Aged; Alloys; Deglutition Disorders; Device Removal; Dilatation; Esophageal Stenosis; Esophagoscopy; Female; Foreign-Body Migration; Humans; Prosthesis Design; Prosthesis Failure; Recurrence; Risk Factors; Stents; Treatment Outcome

This article begins with an overview of the history and development of stents. The material properties unique to the Ultraflex esophageal stent and the Diamond biliary stent along with their clinical benefits are presented in detail. The author also provides detailed product information, recommendations, and contraindications for the use of both stents.

Topics: Alloys; Cholestasis; Coated Materials, Biocompatible; Esophageal Stenosis; Humans; Pliability; Prosthesis Design; Prosthesis Implantation; Stents

Ultraflex esophageal stents have contributed to the tremendous success of self-expanding metal stents (SEMS) in the treatment of esophageal cancer because they are easy and safe to insert. With an eye to improving clinical outcome, the Ultraflex stent design has been in a state of constant evolution since its introduction. However, as with other SEMS, a high reintervention rate remains a challenging problem.

Topics: Alloys; Biocompatible Materials; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Humans; Palliative Care; Plastics; Pliability; Postoperative Complications; Prosthesis Design; Prosthesis Implantation; Stents

To evaluate the therapeutic effect of radiotherapy for esophageal cancer after expandable metallic stent placement.. Ten cases of advanced esophageal cancer were evaluated, 7 having complete obstruction and 3 with digestive-respiratory fistula. Ten nitinol stents were placed at the site of stenosis. Patients were treated with a total dose of 1 200 cGy divided into 3 fractions of 400 cGy 4-7 d after stents placement.. All the 10 stents were placed successfully at one time. After radiotherapy for advanced esophageal cancer, the survival period of the cases ranged from 14 to 22 mo, with a mean survival of 17 mo. No re-stenosis occurred among all the 10 cases.. Stent placement combined with radiotherapy for esophageal cancer is helpful to prolong patients' survival and reduce occurrence of re-stenosis.

Topics: Aged; Aged, 80 and over; Alloys; Coated Materials, Biocompatible; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Membranes, Artificial; Middle Aged; Silicones; Stents; Survival Analysis

To study the therapeutic efficacy of temporary partially-covered metal stent insertion on benign esophageal stricture.. Temporary partially-covered metal stent was inserted in 83 patients with benign esophageal stricture. All the patients had various dysphagia scores.. Insertion of 85 temporary partially-covered metal stents was performed successfully in 83 patients with benign esophageal stricture and dysphagia was effectively remitted in all the 83 cases. The dysphagia score was 3.20+/-0.63 (mean+/-SD) and 0.68+/-0.31 before and after stent insertion, and 0.86+/-0.48 after stent removal. The mean diameter of the strictured esophageal lumen was 3.37+/-1.23 mm and 25.77+/-3.89 mm before and after stent insertion, and 16.15+/-2.96 mm after stent removal. Follow-up time was from 1 week to 96 months (mean 54.26+/-12.75 months). The complications were chest pain (n=37) after stent insertion, and bleeding (n=12) and reflux (n=13) after stent removal.. Temporary partially-covered metal stent insertion is one of the best methods for treatment of benign esophageal stricture.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Stents; Treatment Outcome

Self-expanding metal stents are a promising alternative in the palliation of malignant esophageal obstruction, but the relative value of different stent types is not well established.. During a 3-year enrollment period in four different centers, 82 consecutive patients with malignant dysphagia without tumor recurrence after surgery or esophagorespiratory fistulas received either an uncovered Wallstent (44 patients) or a knitted nitinol stent (38 patients).. Age (median: 79 yr), sex (F:M = 33:67), dysphagia score (median: 3), Karnofsky score (median: 53), body mass index (median: 19), type of pretreatment, tumor stage, stricture length (median: 5.4 cm), and stricture location were comparable in both stent groups. After stent placement, median dysphagia score improved markedly in both groups by two points. Procedure-related mortality (16 vs 0%; p < 0.01), early complication rate (32 vs 8%; p < 0.01), and severe persistent pain after stent placement (23 vs 0%; p < 0.002) were higher in the Wallstent compared with the knitted nitinol stent group. In contrast, stent dysfunction (7 vs 32%; p < 0.005), reintervention rate (9 vs 34%; p < 0.005), and costs were lower in the Wallstent compared with the nitinol stent group.. In malignant esophageal obstruction, both stents markedly improved dysphagia. Uncovered Wallstents seem to cause more early severe complications than knitted nitinol stents. In contrast, stent dysfunction, reintervention rate, and costs appear to be higher in the nitinol stent group.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Body Mass Index; Costs and Cost Analysis; Deglutition Disorders; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Karnofsky Performance Status; Male; Middle Aged; Neoplasm Staging; Pain; Palliative Care; Retreatment; Stents; Surface Properties; Survival Rate

Tumor ingrowth through self-expanding metal stents presents a difficult problem for management. The techniques for treating tumor ingrowth have not yet been well described, and the optimal endoscopic approach is not clear. We have recently used photodynamic therapy (PDT) to treat tumor ingrowth through uncovered nitinol mesh stents.. Four patients (mean age 73) with obstructive adenocarcinomas of the distal esophagus had received self-expanding stents for palliation of their dysphagia. After stent placement, tumor ingrowth had caused progressive dysphagia in all of the patients; the dysphagia was graded on a scale from 0 (normal) to 4 (inability to swallow liquids). All of the patients received PDT treatment.. After PDT, excellent palliation of the dysphagia was seen in all of the patients, with a mean improvement in the dysphagia score of 2.25 and a mean dysphagia-free interval of 92 days. There were no major complications.. The use of PDT to treat tumor ingrowth through self-expanding metal esophageal stents is effective and safe.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Female; Foreign-Body Reaction; Hematoporphyrin Derivative; Humans; Male; Middle Aged; Palliative Care; Photochemotherapy; Photosensitizing Agents; Prognosis; Stents; Survival Rate

Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Alloys; Biocompatible Materials; Carcinoma, Squamous Cell; Equipment Design; Equipment Safety; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Female; Humans; Male; Middle Aged; Palliative Care; Stents; Treatment Outcome

Removal of self-expanding esophageal metal stents that have been implanted for a long time can be difficult and risky.. In this paper, we describe the use of the "inversion technique" under fluoroscopy for removal of self-expandable nitinol esophageal stents that have been placed for long periods and evaluate the effectiveness and safety of the method.. Retrospective analysis of patients who underwent removal of self-expanding nitinol esophageal stents by the inversion technique under fluoroscopy at our center. Demographic characteristics, type of esophageal stents, stent retention time, reasons for stent removal, and related complications were collected from the case records and analyzed.. A total of 112 metal esophageal stents (62 fully covered esophageal stents and 50 partially covered esophageal stents) were extracted from the 107 patients included in the study. Indications for stent implantation were malignant esophageal stenosis (27 patients), benign esophageal stenosis (42 patients), and esophageal fistula (38 patients). Median duration of stent retention was 77 days (29-727 days). All stents were removed successfully without major complications such as esophageal rupture, massive hemorrhage, asphyxia, or cardiorespiratory arrest.. Inversion technique under fluoroscopy appears to be a safe, effective, and quick procedure for removal of self-expanding nitinol esophageal stent after long-term placement.

Topics: Alloys; Device Removal; Esophageal Stenosis; Fluoroscopy; Humans; Metals; Retrospective Studies; Stents; Treatment Outcome

The treatment of recurrent esophageal stricture secondary to the ingestion of a caustic agent is an arduous task. Self-expanding esophageal stents may be an alternative to repeated endoscopic esophageal dilations.. We present the case of a two-year-old male with a severe and long esophageal stricture successfully treated by the combination of dilations and stent placement. After five months of serial pneumatic dilations, three self-expanding nitinol stents internally coated with silicone were introduced through a gastrostomy, covering the entire esophagus. The procedure was performed under endoscopic and radiological guidance. Three months later, the treatment was repeated with a single stent. A new stenosis in the proximal esophagus required surgical resection, and anastomosis followed by two pneumatic dilations for five months resulted in longer intervals where the patient was asymptomatic.. The results obtained were satisfactory, allowing the patient to conserve and use his own esophagus. However, this is a unique case and the optimal maintenance time and withdrawal time of the stent must be determined.

Topics: Alloys; Child, Preschool; Drug Resistance; Endoscopy, Gastrointestinal; Esophageal Stenosis; Gastrostomy; Humans; Male; Stents; Surgery, Computer-Assisted; Treatment Outcome

Attempts have been made to investigate the effect of slip time of nitinol artificial esophagus for forming neo-esophageal stenosis after replacement of a thoracic esophagus with nitinol artificial esophagus in 20 experimental pigs. The pigs whose slip time was less than 90 days postoperatively had severe dysphagia (Bown's III) immediately after they were fed, and the dysphagia aggravated gradually later on (Bown's III-IV). The pigs whose slip time was more than 90 days postoperatively had mild/moderate dysphagia (Bown's I-II) immediately after they were fed, and the dysphagia relieved gradually later on (Bown's II-I-0). The ratios between the diameter of neo-esophagus in different slip time and normal esophagus were 25% (at 2 months postoperatively), 58% (at 4 months postoperatively), and 93% (at 6 months postoperatively), respectively. The relationship between nitinol artificial esophagus slip time and neo-esophageal stenosis showed a positive correlation. After replacement of a thoracic esophagus with nitinol artificial esophagus, the artificial esophageal slip time not only affected the original diameter of the neo-esophagus immediately, but also affected the neo-esophageal scar stricture forming process later on. The narrowing of neo-esophagus is caused by overgrowth of scar tissue. But there is the positive correlation between artificial esophagus slip time and neo-esophageal stenosis, so this can be a way of overcoming neo-esophageal stenosis by delaying slip time of artificial esophagus.

Topics: Alloys; Animals; Artificial Organs; Esophageal Stenosis; Esophagus; Stents; Swine

Placement of self-expandable nitinol stents is useful for the treatment of esophageal and upper gastrointestinal (GI) obstruction. However, complications such as stent migration, tumor overgrowth, and bleeding occur. Although stent migration and tumor overgrowth are well documented in previous studies, the occurrence of bleeding has not been fully evaluated.. To evaluate the incidence, management strategies, and predictors of bleeding after placement of self-expandable nitinol stents in patients with esophageal and upper GI obstruction.. We retrospectively reviewed the medical records and results of computed tomography and endoscopy of 1485 consecutive patients with esophageal and upper GI obstructions who underwent fluoroscopically guided stent placement.. Bleeding occurred in 25 of 1485 (1.7%) patients 0 to 348 days after stent placement. Early stent-related bleeding occurred in 10 patients (40%) and angiographic embolization was used for 5/10. Late bleeding occurred in 15 patients (60%) and endoscopic hemostasis was used for 7/15. Twenty-two of 25 (88%) patients with bleeding had received prior radiotherapy and/or chemotherapy.. Bleeding is a rare complication after placement of expandable nitinol stents in patients with esophageal and upper GI obstruction, but patients with early bleeding may require embolization for control. Care must be exercised on placing stents in patients who have received prior radiotherapy or chemotherapy.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Embolization, Therapeutic; Esophageal Stenosis; Esophagoscopy; Female; Fluoroscopy; Gastrointestinal Hemorrhage; Hemostasis, Surgical; Humans; Incidence; Male; Middle Aged; Patient Selection; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Tomography, X-Ray Computed; Tracheal Stenosis; Treatment Outcome

Topics: Alloys; Cholestasis; Colonic Diseases; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Esophageal Stenosis; Foreign-Body Migration; Humans; Intestinal Atresia; Postoperative Complications; Stents

Self-expandable esophageal stents are increasingly used for palliation or as an adjunct to chemoradiation for esophageal neoplasia. The optimal esophageal stent design and material to minimize dose perturbation with external beam radiation are unknown. We sought to quantify the deviation from intended radiation dose as a function of stent material and mesh density design.. A laboratory dosimetric film model was used to quantify perturbation of intended radiation dose among 16 different esophageal stents with varying material and stent mesh density design.. Radiation dose enhancement due to stent backscatter ranged from 0 % to 7.3 %, collectively representing a standard difference from the intended mean radiation dose of 1.9 (95 % confidence interval [CI] 1.5 - 2.2). This enhancement was negligible for polymer-based stents and approached 0 % for the biodegradable stents. In contrast, all metal alloy stents had significant radiation backscatter; this was largely determined by the density of mesh design and not by the type of alloy used.. Stent characteristics should be considered when selecting the optimal stent for treatment and palliation of malignant esophageal strictures, especially when adjuvant or neo-adjuvant radiotherapy is planned.

Topics: Alloys; Analysis of Variance; Chi-Square Distribution; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Humans; Palliative Care; Polymers; Radiation Dosage; Radiometry; Radiotherapy Dosage; Stainless Steel; Stents; Surgical Mesh

Fully covered esophageal self-expandable metallic stents (SEMS) often are used for palliation of malignant dysphagia. However, experience and data on these stents are still limited. The purpose of this multicenter study was to evaluate the efficacy and safety of fully covered nitinol SEMS in patients with malignant dysphagia.. 37 patients underwent placement of a SEMS during a 3 year period. Five patients underwent SEMS placement as a bridge to surgery: one for tracheoesophageal fistula in the setting of squamous cell carcinoma of the esophagus, one for perforation in setting of esophageal adenocarcinoma, 27 for unresectable esophageal cancer (16 adenocarcinoma, 11 squamous cell carcinoma), two for lung cancer, and one for breast-cancer-related esophageal strictures.. SEMS placement was successful in all 37 patients. Immediate complications after stent deployment included chest pain (n = 6), severe heartburn (n = 1), and upper gastrointestinal bleeding requiring SEMS revision (n = 1). Dysphagia scores improved significantly from 3.2 ± 0.4 before stent placement to 1.4 ± 1.0 at 1 month (P < 0.0001), 1.1 ± 1.2 (P < 0.0001) at 3 months, and 1.3 ± 1.4 (P = 0.0018) at 6 months. The stent was removed in 11 patients (30%) for the following indications: resolution of stricture (n = 3), stent malfunction (n = 5), and stent migration (n = 3). After stent removal, three patients were restented, three underwent dilation, and two underwent PEG placement. Mean survival for the 37 patients after stent placement was 146.3 ± 143.6 (range, 13-680) days.. Our study suggests that fully covered SEMS placement improve dysphagia scores in patients with malignant strictures, particularly in the unresectable population. Further technical improvements in design to minimize long-term malfunction and migration are required.

Topics: Aged; Alloys; Deglutition Disorders; Device Removal; Esophageal Neoplasms; Esophageal Stenosis; Female; Fluoroscopy; Foreign-Body Migration; Humans; Male; Middle Aged; Prosthesis Failure; Radiography, Interventional; Stents; Treatment Outcome

The purpose of this study was to evaluate the clinical effectiveness of polytetrafluoroethylene (PTFE)-covered retrievable expandable nitinol stents in patients with malignant esophageal strictures and to identify prognostic factors associated with clinical outcomes.. From 2001 to 2010, 320 PTFE-covered stents were placed in 270 patients. Technical and clinical success, complications, survival, and stent patency were measures of clinical effectiveness. The relationships among complications and age, sex, stricture location, stricture length, chemotherapy alone, chemoradiotherapy, and malignancy source were examined. Independent prognostic factors of overall survival and stent patency were identified.. Stent placement and removal were technically successful and tolerated without procedural complications, and 98% of patients achieved clinical success. The complication rate was 30%. Two removed stents exhibited covering membrane separation. Chemotherapy was associated with increased stent migration (p = 0.002). Stricture location and chemoradiotherapy were associated with esophagorespiratory fistula development (p = 0.033 and p < 0.001, respectively). Median and mean survival periods were 114 days (95% CI, 102-126 days) and 166 days (138-193 days). Chemotherapy and chemoradiotherapy were independent prognostic factors for survival (p = 0.050 and p = 0.032, respectively). The median and mean stent patency periods were 60 days (41-79 days) and 90 days (71-108 days). Chemoradiotherapy was the only independent prognostic factor for stent patency (p = 0.012).. The PTFE-covered stents were clinically effective. Membrane degradation was not evident, although 0.7% of the patients experienced covering membrane separation. Chemotherapy was associated with increased migration and prolonged survival. Chemoradiotherapy was associated with increased esophagorespiratory fistula formation and decreased stent patency.

Topics: Alloys; Coated Materials, Biocompatible; Combined Modality Therapy; Device Removal; Esophageal Neoplasms; Esophageal Stenosis; Female; Fluoroscopy; Foreign-Body Migration; Humans; Male; Middle Aged; Polytetrafluoroethylene; Prognosis; Proportional Hazards Models; Radiography, Interventional; Retrospective Studies; Risk Factors; Stents; Survival Rate; Treatment Outcome

To explore long-term effect of the treatment of refractory benign esophageal strictures with a novel retrievable fully covered stent made of nitinol alloy.. From November 2009 to May 2011, the stents were placed in 8 patients with refractory benign esophageal strictures in the Department of Thoracic Surgery at the Cancer Center of Sun Yat-sen University. Esophago-gastro-duodenoscopy and barium swallow examinations were performed respectively on the 1st, 7th, 30th, 60th day after implantations of the stents and 1,2,3,6 months or even longer after removal of the stents in order to assess the long-term effect on the improvement of dysphagia and the development of complications.. The stents were successful deployed in all the patients. The dysphagia scores were improved instantly and significantly as compared to the preoperative scores(P<0.05). Seven patients had long-term improvement of dysphagia. The dwelling time of all the stents ranged from 4 to 60 weeks, with a median of 16.8 weeks. Six patients had their stent removed after a dwelling time of 4 to 18 weeks(median 9.7 weeks). The follow-up period was 1.5-9 months (median 6.1 months). The improvement of dysphagia was also significant during follow-up after removal of the stents(P<0.05). At the most recent follow up, two patients still had the stent in place. The first one has already been followed up for 15 months and was still on regular diet. The other one experienced improvement of dysphagia score up to two months after placement, but downgraded to 3 by the third month. Relapse of stenosis occurred in 1 patient, migration in 2 patients, and tissue hyperplasia in 3 patients, of whom 2 developed inward growth of granulation tissue due to the rupture of the covering membrane.. The new retrievable fully covered stent made of nitinol alloy significantly improves the swallowing function of patients with intractable benign esophageal strictures after implantation and after removal of the stents, with low incidence of long-term restenosis. However, the high rate of migrations and the poor quality of the covering membrane further implies that the design of the new stent still needs to be improved.

Topics: Adult; Aged; Alloys; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Prosthesis Implantation; Stents; Treatment Outcome

We evaluated the effectiveness of a double-layered polytetrafluoroethylene (PTFE)-covered nitinol stent in the palliative treatment of malignant esophageal strictures. A double-layered PTFE-covered nitinol stent was designed to reduce the propensity to migration of conventional covered stent. The stent consists of an inner PTFE-covered stent and an outer uncovered nitinol stent tube. With fluoroscopic guidance, the stent was placed in 32 consecutive patients with malignant esophageal strictures. During the follow-up period, the technical and clinical success rates, complications, and cumulative patient survival and stent patency were evaluated. Stent placement was technically successful in all patients, and no procedural complications occurred. After stent placement, the symptoms of 30 patients (94%) showed improvement. During the mean follow-up of 103 days (range, 9-348 days), 11 (34%) of 32 patients developed recurrent symptoms due to tumor overgrowth in five patients (16%), tumor ingrowth owing to detachment of the covering material (PTFE) apart from the stent wire in 3 (9%), mucosal hyperplasia in 2 (6%), and stent migration in 1 (3%). Ten of these 11 patients were treated by means of placing a second covered stent. Thirty patients died, 29 as a result of disease progression and 1 from aspiration pneumonia. The median survival period was 92 days. The median period of primary stent patency was 190 days. The double-layered PTFE-covered nitinol stent seems to be effective for the palliative treatment of malignant esophageal strictures. We believe that the double-layer configuration of this stent can contribute to decreasing the stent's migration rate.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polytetrafluoroethylene; Radiography; Radiology, Interventional; Recurrence; Stents; Survival Analysis; Treatment Outcome; Vascular Patency

To compare 2 different types of covered esophageal nitinol stents (Ultraflex and Choostent) in terms of efficacy, complications, and long-term outcome.. A retrospective review of a consecutive series of 65 patients who underwent endoscopic placement of an Ultraflex stent (n = 33) or a Choostent (n = 32) from June 2001 to October 2009 was conducted.. Stent placement was successful in all patients without hospital mortality. No significant differences in patient discomfort and complications were observed between the Ultraflex stent and Choostent groups. The median follow-up time was 6 mo (inter-quartile range 3-16 mo). Endoscopic reintervention was required in 9 patients (14%) because of stent migration or food obstruction. No significant difference in the rate of reintervention between the 2 groups was observed (P = 0.8). The mean dysphagia score 1 mo after stent placement was 1.9 +/- 0.3 for the Ultraflex stent and 2.1 +/- 0.4 for the Choostent (P = 0.6). At 1-mo follow-up endoscopy, the cover membrane of the stent appeared to be damaged more frequently in the Choostent group (P = 0.34). Removal of the Choostent was possible up to 8 wk without difficulty.. Ultraflex and Choostent proved to be equally reliable for palliation of dysphagia and leaks. Removal of the Choostent was easy and safe under mild sedation.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Device Removal; Esophageal Fistula; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Palliative Care; Retrospective Studies; Stents; Treatment Outcome

Topics: Aged; Alloys; Catheterization; Coated Materials, Biocompatible; Colon; Device Removal; Equipment Failure Analysis; Esophageal Stenosis; Female; Foreign-Body Migration; Humans; Radiography; Recurrence; Silicone Elastomers; Stents

Topics: Alloys; Esophageal Neoplasms; Esophageal Stenosis; History, 20th Century; History, 21st Century; Humans; Palliative Care; Patient Selection; Prosthesis Design; Prosthesis Implantation; Stents; Treatment Outcome

The aim of this study in canines was to investigate the effectiveness and safety of self-expandable metal stents, which were coated with paclitaxel to minimize the tissue response.. 14 dogs (5-10 kg) were randomly allocated to two groups. Drug-eluting stents (DES, n = 7) or nondrug-eluting stents (non-DES, n = 7) were endoscopically inserted and fixed in the esophagus of healthy dogs. Every 2 weeks, for a maximum period of 8 weeks, an endoscopic examination was performed to evaluate the status of stent insertion, the grade of tissue hyperplasia, and mucosal change at both ends of the stent.. One case of stent migration was observed after 4 weeks in the non-DES group. In this group, tissue reaction and hyperplasia remained for more than 4 weeks after stent insertion. By contrast, an endoscopic examination of the surrounding esophageal mucosa in the DES group showed very little tissue reaction, and the stent was easily separated from the esophageal tissue.. Although further studies are required to confirm our results, we suggest that these newly designed DES may provide an alternative tool to manage refractory benign esophageal stricture.

Topics: Alloys; Animals; Antineoplastic Agents, Phytogenic; Cell Division; Disease Models, Animal; Dogs; Drug-Eluting Stents; Epithelium; Equipment Design; Esophageal Stenosis; Esophagoscopy; Esophagus; Focal Adhesions; Granulation Tissue; Mucous Membrane; Paclitaxel

We sought to test the feasibility and technical ease of a newly designed nitinol-based modified esophageal stent and its effects on preventing postcaustic stricture in mongrel dogs and to try to explain the result at the molecular level.. Twenty-four dogs were included in this controlled study. Stenosis index (wall thickness/intraluminal diameter), pathologic features, hydroxyproline quantities, esophageal compliance, and biomechanics were compared between the injured but unstented and stented dogs. Transforming growth factor beta1, Sma/Mad (Smad)3, and Smad7 mRNA expression and protein levels in esophageal tissue were detected by means of reverse transcriptase-polymerase chain reaction and Western blotting, respectively.. The modified esophageal stent was able to be placed and retrieved successfully and conveniently and was not only intact but there was also no macroscopic esophageal mucosal injury after the stent removal 4 months later. In comparison with the injured but unstented group, esophageal compliance, biomechanics, and the stenosis index were significantly better in the stented group. Histopathologic study revealed that collagen bundles were thinner and its orientation tended toward a regular and parallel pattern. Transforming growth factor beta1 and Smad3 mRNA expression and protein levels increased and Smad7 mRNA expression and protein levels decreased significantly in esophageal tissue in the stented group. These variables showed no statistically significant difference 2 months after stent removal.. The modified esophageal stent might be a promising stent in preventing stricture formation after corrosive esophageal burns clinically.

Topics: Alloys; Animals; Biomechanical Phenomena; Blotting, Western; Body Weight; Burns, Chemical; Caustics; Compliance; Dogs; Equipment Design; Esophageal Stenosis; Esophagus; Feasibility Studies; Hydroxyproline; Proteins; Reverse Transcriptase Polymerase Chain Reaction; RNA, Messenger; Smad3 Protein; Smad7 Protein; Stents; Transforming Growth Factor beta1

Dysphagia is the most common disabling symptom in patients with inoperable esophagogastric carcinoma. Self-expanding metal stents are highly effective in the palliation of these patients.. In 35 patients with inoperable carcinoma of the esophagus or the stomach, with recurrent tumor or complications after transhiatal esophagectomy or gastrectomy or with esophageal stenosis caused by pulmonary cancer, a self-expanding nitinol stent was placed to reduce dysphagia. Dysphagia and WHO performance status were assessed, before and after stent placement.. In 35 patients, 39 stents were placed without technical problems. Dysphagia improved significantly. The WHO performance status remained stable. Mean survival of all patients was 11 weeks. Major complications occurred in 3 patients. One patient died of massive tumor bleeding. Minor complications such as stent migration or retrosternal pain occurred in 5 patients. In 2 patients the migrated stent could successfully be placed in the correct position after giving ice-cooled water through the endoscope. Four patients had esophagorespiratory fistulas which were all initially successfully occluded.. This nitinol stent is highly effective for improving dysphagia in patients with malignant esophagogastric obstruction. We observed no procedure-related complications. Bleeding was the principal major complication. The early intake of cold beverages resulted in stent migration. Recurrent dysphagia due to overgrowth by tumor or nonmalignant tissue remains a problem. Technical improvements are desirable to reduce the overgrowth by nonmalignant tissue.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Esophagectomy; Female; Gastrectomy; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Prosthesis Implantation; Statistics, Nonparametric; Stents; Stomach Neoplasms; Time Factors; World Health Organization

To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures.. Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated.. A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P=0.002 and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n=3), tracheal compression by the esophageal stent (n=3), new fistula development due to covering membrane degradation of the esophageal stent (n=1), and symptomatic sputum retention (n=1). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of 72.50 days (range 7-375 days).. Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures.

Topics: Adult; Aged; Alloys; Bronchial Diseases; Constriction, Pathologic; Esophageal Fistula; Esophageal Stenosis; Esophagus; Female; Follow-Up Studies; Head and Neck Neoplasms; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Postoperative Complications; Radiography; Retrospective Studies; Stents; Survival Rate; Trachea; Tracheal Stenosis; Treatment Outcome

To assess the clinical effectiveness of temporary metallic stent placement with concurrent radiation therapy in patients with esophageal carcinoma by comparing it with permanent stent placement with concurrent radiation therapy.. Covered retrievable expandable nitinol stents were placed in 47 patients with esophageal carcinoma 1 week before starting radiation therapy; the stents were electively removed 4 weeks after placement in 24 patients (group A), while not electively removed in the other 23 patients (group B). In cases of complications, the stents were also removed from patients in groups A and B. The dysphagia score, complications (severe pain, granulation tissue formation, stent migration, esophagorespiratory fistula, and hematemesis), tumor overgrowth/regrowth, reintervention rates, and dysphagia-progression-free and overall survival rates were compared in the two groups.. Stent placement or removal was technically successful and well tolerated in all patients. The dysphagia score was significantly improved in both groups after stent placement (P < .01). Each of the stent-related complications was less in group A than in group B but there was no significant difference. However, the total number of patients with one or more than one complications and who needed related reinterventions was significantly less in group A than in group B (P = .042 and .030, respectively). Tumor overgrowth/regrowth and the total number of patients who required related reinterventions was not significantly different (P = 1.00 and .517, respectively). Dysphagia-progression-free and overall survival rates were significantly longer in group A than in group B (P = .005 and .001, respectively).. Temporary placement of a covered retrievable expandable metallic stent with concurrent radiation therapy for patients with esophageal carcinoma is beneficial for reducing complications and related reinterventions and for increasing resultant survival rates compared with permanent esophageal stent placement.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Carcinoma, Squamous Cell; Case-Control Studies; Coated Materials, Biocompatible; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Korea; Male; Middle Aged; Polyurethanes; Postoperative Complications; Prospective Studies; Retrospective Studies; Stents; Survival Analysis

Esophageal stenting is a popular form of treatment of esophageal strictures in adults but is not widely used in children. The aim of the current study was to investigate whether esophageal stents could be used safely and effectively in the treatment of esophageal stenosis in children.. Covered retrievable expandable nitinol stents were placed in 8 children with corrosive esophageal stenosis. The stents were removed 1 to 4 weeks after insertion.. The stents were placed in all patients without complications and were later removed successfully. After stent placement, all patients could take solid food without dysphagia. Stent migration occurred in one patient and so the insertion procedure was repeated to reposition the stent. During the 3-month follow-up period after stent removal, all children could eat satisfactorily. After 6 months, 2 children required balloon dilation (3 times in one and 5 times in the other). The dysphagia score improved in all patients.. The use of the covered retrievable expandable stent is an effective and safe method in treating childhood corrosive esophageal stenosis.

Topics: Alloys; Burns, Chemical; Catheterization; Caustics; Chest Pain; Child; Child, Preschool; Conscious Sedation; Deglutition Disorders; Device Removal; Esophageal Stenosis; Female; Fluoroscopy; Follow-Up Studies; Foreign-Body Migration; Humans; Hydrochloric Acid; Hydrogen Peroxide; Male; Pliability; Radiography, Interventional; Severity of Illness Index; Sodium Hydroxide; Stents; Sulfuric Acids; Temperature; Treatment Outcome; Vomiting

The aim of this retrospective study was to present and compare the results of using two different types of esophageal self-expanding stents (uncovered and covered) for palliative treatment of patients with inoperable malignant stenosis of the esophagus and cardia. Over a period of 8 years, 152 patients underwent fluoroscopically guided insertion of metal esophageal stents. We inserted uncovered esophageal nitinol Strecker stents in 54 patients (group I) and covered esophageal Ultraflex stents in the remaining 98 patients (group II). The stent insertion procedure was successively performed in all patients. Closure of esophageal fistula by covered stents was achieved in 8/8 patients. Mean dysphagia score was significantly decreased in both patient groups at 4 weeks follow-up: from 2.73 before stent insertion to 0.15 in group I, and from 2.67 to 0.05 in group II (on 0-4 scale). Eighty-eight per cent of patients with covered stents and 54% with uncovered type were free of symptoms during follow-up. Complications occurring during follow-up and their comparative frequency in the two groups of patients were as follows (group I: group II%): stent migration (0:10%); tumor or granulation tissue ingrowth (100:53%); overgrowth at the ends of stents (17:30%); restenosis causing recurrent dysphagia (37:8%); and appearance of esophageal fistulas (8:6%). In conclusion, fluoroscopically guided insertion of self-expandable esophageal stents is a safe and comfortable method of palliation for patients suffering with malignant dysphagia. In selection of a stent, covered types should be given priority for prevention of restenosis.

Topics: Aged; Alloys; Cardia; Deglutition Disorders; Equipment Design; Equipment Failure; Esophageal Fistula; Esophageal Neoplasms; Esophageal Stenosis; Female; Fluoroscopy; Follow-Up Studies; Granulation Tissue; Humans; Male; Middle Aged; Palliative Care; Radiography, Interventional; Recurrence; Retrospective Studies; Stents; Surface Properties; Surgical Mesh

Topics: Adenocarcinoma; Aged; Alloys; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Fatal Outcome; Humans; Intestinal Obstruction; Laparotomy; Male; Palliative Care; Pneumonia, Aspiration; Prosthesis Failure; Radiography, Abdominal; Stents

Two types of self-expanding metal stents to palliate dysphagia in patients with unresectable malignant oesophageal strictures have been compared.. From February 1996 to October 2000, 50 metal stents (23 covered Ultraflex and 27 Esophacoil) were placed in 50 patients (40 males, mean age: 67+/-12 years, range: 33-100, mean dysphagia score: 3.18+/-0.66) with unresectable malignant oesophageal strictures. Patients were followed until death. A retrospective review has been made of a prospectively collected database.. The two groups were comparable as far as concerns degree of dysphagia, location and stricture length. Stent placement was successful in all cases. Covered Ultraflex stent was placed in 2 patients with oesophagobronchial fistula. No procedure-related deaths were seen. Early severe complications occurred in 2 patients (perforation in 1 and tumour bleeding in 1, in the Esophacoil group). Nine patients and 1 patient complained of pain following Esophacoil and Ultraflex stent placement, respectively. Late complications were asymptomatic rupture of distal Esophacoil rings in 2 patients, symptomatic Ultraflex stent migration in 2 and tumour overgrowth in 3 (Esophacoil 1, Ultraflex 2). Mean dysphagia score at 4 weeks after stent placement was 1.9+/-0.77. Mean survival was 177+/-109 days (range: 35-603 days). There were no significant differences in technical success, dysphagia palliation, complications (except chest pain) and survival using the two types of stent.. Self-expanding metal stents are safe with high technical success and achieve satisfactory long-term palliation for dysphagia. The covered Ultraflex and Esophacoil stents are equally effective.

Topics: Aged; Alloys; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Female; Humans; Male; Palliative Care; Retrospective Studies; Stents

The authors report their experience with three types of retrievable covered nitinol stents in patients with malignant esophageal strictures.. Three types of retrievable covered nitinol stents were designed. Type A stents were placed in 45 patients, type B stents were placed in 29 patients, and type C stents were placed in 34 patients. The stents were removed with use of a stent retrieval set under fluoroscopic guidance when the stents caused complications. Stent patency, symptom relief, survival rate, and complications were analyzed relative to stent type and radiation therapy.. The timing of radiation and the stent type have significant effects on occurrence of complications such as stent migration and fistula formation (P =.002 and P = 0.029, respectively). Complications were significantly more frequent in patients with the type B stent than those with type A or type C stents (P =.008). Patients who underwent radiation therapy before stent placement or who underwent no radiation therapy experienced substantially less complications than those who underwent radiation therapy after stent placement (P =.005 and P <.001, respectively). The survival period was significantly longer in patients who underwent radiation therapy after stent placement than in the other groups (P =.034). Stents were removed from 15 patients (14%) 2 days to 16 weeks (mean, 4 weeks) after stent placement as a result of severe pain (n = 7), stent migration (n = 6), or stent deformity (n = 2). Stent removal was well tolerated in all patients.. Use of retrievable covered nitinol stents seems to be a safe and effective method of treatment in patients with malignant esophageal strictures. However, removal of the stents was needed in 14% of the patients because of complications. Patients who underwent radiation therapy after stent placement and those with the type B stent experienced more complications than other patients.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Palliative Care; Regression Analysis; Stents; Survival Analysis

Topics: Adenocarcinoma; Aged; Alloys; Deglutition Disorders; Equipment Failure Analysis; Esophageal Neoplasms; Esophageal Stenosis; Fatal Outcome; Humans; Male; Palliative Care; Stents; Ventricular Fibrillation

To investigate the safety and clinical effectiveness of covered retrievable expandable nitinol stents in 25 patients with a benign esophageal stricture.. Under fluoroscopic guidance, covered retrievable expandable nitinol stents were placed in 25 patients with a benign esophageal stricture and were removed with a retrieval hook 1-8 weeks later.. Stent placement was successful in all patients, with no procedural complications. After stent placement, all patients could ingest solid food. The stents were successfully removed from all but two patients. One patient passed the stent via the rectum, and the other regurgitated a high cervical stent. After stent removal, one patient developed a small esophagobronchial fistula, which spontaneously sealed within 1 week of stent removal. After stent removal or migration, all patients could ingest solid food. During follow-up (mean, 13 months; range, 2-25 months) after stent removal or migration, 12 patients maintained their improvement in dysphagia and needed no further treatment. Thirteen patients with recurrence were treated by means of repeat balloon dilation.. Use of retrievable expandable nitinol stents seems to be a safe and effective method of treatment in selected patients with benign esophageal strictures.

Topics: Adult; Aged; Alloys; Esophageal Stenosis; Female; Fluoroscopy; Humans; Male; Middle Aged; Radiography, Interventional; Stents

Topics: Alloys; Carcinoma, Squamous Cell; Endoscopy; Esophageal Neoplasms; Esophageal Stenosis; Foreign-Body Migration; Humans; Palliative Care; Stents

The purpose of this study was to determine the efficacy of the uncovered coil stents in patients with malignant dysphagia. Coiled spring-shaped uncovered self-expanding metallic Esophacoil stents (Instent, Eden Prairie, Minnesota) were placed in 11 patients (9 men and 2 women; age range 38-77 years, mean age 60.5 years) with malignant esophageal strictures and dysphagia, under fluoroscopic guidance. Dysphagia was graded on a scale of 0 to 4 (0 = no dysphagia; 1 = dysphagia to normal solids; 2 = dysphagia to soft solids; 3 = dysphagia to solids and liquids; 4 = complete dysphagia, inability to swallow saliva). Two patients had received radiation therapy, 4 had had chemotherapy, and 5 had had a combination of both radiation and chemotherapy before stent palliation. Control clinical examinations and endoscopic or barium swallow studies were performed every 4 weeks until the patient died. The stents were well tolerated by all patients and were effective in 9 of 11 patients with malignant dysphagia. Complications of the procedure included incomplete opening of the stent in 1 case, migration in 1 case, transient pain in 8 cases, reflux in 3 cases and minor gastrointestinal bleeding in 2 cases. Stent migration in 1 case resulted in surgical intervention and incomplete opening of the stent allowed only partial improvement of dysphagia in 1 case. The quality of life significantly improved in all other patients. Mean survival time of the patients was 73 days (range 34-125 days) and no significant tumor ingrowth was detected during the follow-up period. Insertion of an Esophacoil has a good palliative effect on dysphagia in patients with malignant esophageal strictures with few complications. Although the stent is uncovered, tumor ingrowth and overgrowth were not observed in our study, possibly because of previous treatments.

Topics: Adult; Aged; Alloys; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Palliative Care; Radiography; Stents; Treatment Failure; Treatment Outcome

To evaluate the long-term palliative effect of self-expanding nitinol esophageal stents in patients with malignant dysphagia.. One hundred patients with severe dysphagia secondary to malignant esophageal strictures were treated with self-expanding nitinol stents. The strictures were caused by squamous carcinoma (n = 43), adenocarcinoma (n = 28), anastomotic tumor recurrence (n = 14), and mediastinal tumor (n = 15).. One hundred six stents were successfully positioned in 100 patients. Attempts to insert a second, coaxial stent were unsuccessful in two patients; a second stent was placed incorrectly in another patient. Statistically significant (P < .001) reduction of dysphagia was noted after expansion of the stents. Complications consisted of incomplete expansion secondary to stent twisting (n = 4), stent migration (n = 4), tumor ingrowth (n = 17), tumor overgrowth (n = 3), food impaction (n = 5), fracture of stent wires (n = 2), benign strictures at stent edges (n = 2), tumor bleeding (n = 3), and esophagorespiratory fistula (n = 5). The primary patency rate was 75% (77 of 102 stents); the secondary patency rate was 94% (96 of 102 stents). The survival time (mean, 6.2 months; range, 0.1-47 months) varied with the diagnosis.. Placement of self-expanding nitinol stents is safe and has a good long-term palliative effect on dysphagia in patients with malignant esophageal strictures.

Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Alloys; Anastomosis, Surgical; Carcinoma, Squamous Cell; Deglutition Disorders; Equipment Design; Equipment Failure; Esophageal Fistula; Esophageal Neoplasms; Esophageal Stenosis; Evaluation Studies as Topic; Female; Follow-Up Studies; Food; Foreign-Body Migration; Hemorrhage; Humans; Longitudinal Studies; Male; Mediastinal Neoplasms; Middle Aged; Neoplasm Recurrence, Local; Palliative Care; Respiratory Tract Fistula; Stents; Surface Properties; Survival Rate

The endoscopic methods of palliative treatment in malignant esophageal stenoses caused by neoplasm which have been performed so far unfortunately do not provide permanently satisfying results. The implantation of self-expanding stents with the purpose of removing malignant esophageal obstructions has recently become the most acceptable method of treatment. By using that method it is possible to reduce or even completely remove difficulties in swallowing. In that way a significant improvement in life quality of patients with inoperable esophageal cancer is possible. The various types of metal endoprostheses used for the palliative treatment of esophageal malignant stenoses are described in this paper. Here is also presented a case of nitinol stent implantation in a 50 year old woman suffering from esophageal cancer. This type of therapeutic treatment has been applied in Croatia for first time.

Topics: Alloys; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Female; Humans; Middle Aged; Palliative Care; Stents

A thermal-shaped memory metal stent, which is made of Nitinal, used in 95 patients with malignant tumors and 35 patients with anastomosis stenosis tumor resection. All patients had no opportunities of surgical operation and no response to dilation radiotherapy, chemotherapy, lasertherapy and traditional Chinese medicine. Dysphagia ameliorated in all patients after stent therapy. The mean dysphagia grade varied from 3.71 +/- 0.45(range 3-4) to 1.08 +/- 0.59 (range 0-2)(P < 0.01). Complications occurred in 49 patients (31.5%), including chest pain in 36, local bleeding in 5, tumor overgrowth in 4, stent migration in 2, and food obstraction in 2. In summary, treatment with placement of a Nitinol stent is effective, safe and simple in our patients with dysphagia which were due to malignant esophageal and cardiac strictures and is feasible for some benign esophageal and cardiac strictures as well through our clinical practice and observation nearly three years.

Topics: Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Stents

Topics: Adenocarcinoma; Alloys; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Palliative Care; Stents

To evaluate the usefulness of self-expanding nitinol stents in the palliative treatment of malignant dysphagia.. Eighty self-expanding nitinol stents were placed in 59 patients (43 men, 16 women; mean age, 55 years; age range, 23-75 years) with inoperable malignant stenosis due to squamous cell carcinoma of the esophagus (n = 36), adenocarcinoma (n = 19), invasion of the esophagus due to carcinoma of the lung (n = 2), and recurrent anastomotic carcinoma (n = 2). Dysphagia was graded on a scale of 0 to 3. Follow-up esophagograms were obtained to evaluate stent patency.. Stent placement was successful in all patients. The severity of dysphagia decreased at least one grade in all but one patient. Tumor ingrowth and overgrowth were seen in 21 (36%) patients 2 days to 7 months after stent placement and caused recurrent dysphagia. These 21 patients underwent balloon dilation and additional stent placement. A mediastinal fistula was seen in three patients (5%), ulceration in four (7%), stent torsion in three (5%), and incomplete expansion of the stent in two (2%). Repeat intervention was necessary in 51% of the patients.. There is a substantial range of drawbacks and complications associated with the use of self-expanding nitinol stents for palliation of malignant esophageal strictures. A covering would be necessary to prevent tumor ingrowth.

Topics: Adenocarcinoma; Adult; Aged; Alloys; Carcinoma, Squamous Cell; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Esophagus; Female; Humans; Lung Neoplasms; Male; Middle Aged; Neoplasm Recurrence, Local; Palliative Care; Radiography; Stents

The purpose of this study was to evaluate technical and clinical results of self-expanding esophageal stent implanted in patients with malignant esophageal strictures and clinically significant dysphagia. From June 1992 to September 1994, 27 patients with inoperable tumors of the esophagus or gastric cardiac were treated by placement of 37 self-expanding nitinol stents. Water-soluble contrast and endoscopy studies were performed after the procedure and during the follow-up period. Successful stenting of the stricture was achieved in 27 patients. The mean dysphagia grade dropped from 2.3 to 1 (SD +/- 0.54) immediately after the procedure. After the insertion of the stent, 16 patients died in a period of time ranging from 0 to 13 months (mean 5.6 months), whereas at the end of the study 11 patients were alive 4-15 months after the procedure (mean 8.3 months). No major complications were observed. The results of this study are encouraging because esophageal stent placement was technically easy and clinically effective.

Topics: Adenocarcinoma; Aged; Alloys; Carcinoma, Squamous Cell; Cardia; Catheterization; Contrast Media; Deglutition Disorders; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Female; Fluoroscopy; Follow-Up Studies; Humans; Male; Palliative Care; Radiography, Interventional; Retrospective Studies; Solubility; Stents; Stomach Neoplasms; Survival Rate; Water

A 57-year-old man was admitted because of dysphagia. Two year earlier, endoscopic ND-YAG laser treatment had been performed for squamous cell carcinoma of the tracheal carina. The esophagus was compressed and narrowed by invasion of lung cancer. After ballooning, under endoscopic and fluoroscopic control, a self-expanding nitinol stent (SENS, Ultraflex, Microvasive) was implanted in the esophagus. Immediately after esophageal prosthesis implantation, severe dyspnea and stridor developed because of tumor strictures in the left main bronchus. Under fluoroscopic and guide-wire control, SENS (Accuflex, Microvasive) was implanted in the tracheobronchial tree. Dyspnea, dysphagia and stridor were markedly improved after placement of two nitinol stents. Highly flexible, knitted, self-expanding nitinol stent is made of a nickel titanium alloy. Although the implantation of SENS in tracheobronchial stenosis has not previously been reported, it should be useful for prevention of airway obstruction.

Topics: Alloys; Carcinoma, Squamous Cell; Esophageal Stenosis; Humans; Lung Neoplasms; Male; Middle Aged; Quality of Life; Stents; Tracheal Stenosis

Metal mesh stents are a new way in the treatment of malignant stenoses. Between 11/91 and 12/93 in 79 patients with malignant stenoses of the esophagus and the esophago-gastric junction 96 highly elastic, knitted, self-expanding nitinol stents (Ultraflex, Boston Scientific) were implanted. Most of the tumors being problematic, preoperated or preradiated, in 78 of 96 implantations endoscopic pretreatment (Laser, Argon Plasma Coagulation (APC), dilatation)--mostly in the same session--was necessary. Follow up time was 21 (2-108) weeks. In this pilot study 3.5 (1-27) controlendoscopies with 2.5 (1-10) endoscopic interventions were performed. 90 of 96 implantations were primarily successful and led to a functional success in 73 of 79 patients. The ability to swallow improved significantly, the score of dysphagia improved from 3.5 to 1.0 (p < 0.001). There were no relevant complications and no stent-related mortality. All stents could be kept patent during the follow up period using the new developed Argon-plasma-coagulation (APC) to treat the ingrowth of granulation tissue or tumor, which was observed during follow up in 72 of 93 implantations. Tumor ingrowth represents the main problem of the method and demands endoscopic posttreatment (APC) in cases with relevant re-obstruction. Impairment of the stent lumen by tumor ingrowth (granulation tissue plays no role) would have been observed in about 60% of the patients without such a treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Elasticity; Electrocoagulation; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopes; Female; Follow-Up Studies; Humans; Male; Middle Aged; Palliative Care; Pilot Projects; Stents; Surface Properties

Thirty patients with incurable malignant obstruction of the oesophagus and cardia were treated with self expanding oesophageal memory metal stents (Ultraflex) in a prospective study. The endoprostheses were successfully placed in all patients. Within one week after implantation dysphagia had improved in 25 of 30 patients (83%). Stent expansion was incomplete within one week after implantation in 12 of 30 patients (40%). After an average of two dilatation sessions eight of 12 stents had expanded completely. Five patients complained of retrosternal pain and three of them suffered from heartburn over several days despite acid inhibition. Major problems in the follow up period occurred in 10 of 30 patients (30%) and included late perforation (one) and tumour ingrowth/overgrowth (nine). All of these complications were treated endoscopically. Improvement of the dysphagia of the patients with tumour ingrowth/overgrowth lasted for about eight weeks (median; range: 2-38 weeks). Until November 1994 six of 30 patients were still alive with a survival time of 309 days (median; range: 103-368 days). It is concluded that oesophageal memory metal stents are easy to implant, prove effective in the palliation of malignant oesophageal obstructions, and have a low risk of severe complications. The only disadvantages are that incomplete initial stent expansion as well as tumour ingrowth/overgrowth occurred in nearly one third of the patients.

Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Alloys; Carcinoma; Carcinoma, Squamous Cell; Cardia; Esophageal Neoplasms; Esophageal Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Palliative Care; Prospective Studies; Stents; Stomach Neoplasms

Palliative treatment methods for esophageal and cardiac cancer include dilation, laser vaporization and other thermal methods, alcohol injection, and stent insertion. None of these procedures, however, has proved to be a simple, well-tolerated, and lasting method. We present here our results with a new, highly flexible self-expanding metal stent made of nitinol, which is considered to be particularly useful for difficult (long and tortuous) malignant strictures.. From November 1991 to December 1994, 114 patients with unresectable esophagogastric malignancies or tumor recurrences (92 men, 22 women, mean age 64 years) were treated using 138 highly flexible meshed self-expanding metal stents. Regular clinical and endoscopic follow-up was performed, and stent obstruction or overgrowth was treated by argon plasma coagulation (APC). Patients were followed up until death (n = 78; average follow-up 17 weeks, range 1-90 weeks). Thirty-six patients were alive in December 1994 and had had an average of 20 weeks of follow-up (range 1-160 weeks).. Stent insertion was technically successful in 97% of cases, and led to a reduction of dysphagia (graded 0-4) from a mean score of 3.5 to a mean score of 1.5. Preparatory treatment to open tight strictures was necessary in 80% of cases. Balloon dilation to support stent expansion was carried out in 42 patients (37%). During follow-up, tumor ingrowth occurred in 66% of cases after a mean of seven weeks, and was successfully treated by APC. Including preparatory treatment and re-treatment, patients underwent a mean of 3.5 endoscopic procedures (range 1-12 procedures), which led to good clinical success in 73% of cases. Ninety-six percent of the patients continued to be able to swallow (dysphagia score < or = 2) during follow-up.. Highly elastic self-expanding metal stents can be successfully implanted in the majority of patients, particularly in those with difficult malignant strictures not easily amenable to other methods. The devices provide good palliation with effective relief of dysphagia, easy handling and implantation, and offer a satisfactory quality of life to the patient. However, tumor ingrowth is a significant problem, even though it can be successfully managed by APC. Adequate covering of the stent that does not affect its mechanical properties or firm anchoring should solve at least some of these problems.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Electrocoagulation; Esophageal Stenosis; Esophagoscopes; Esophagus; Female; Follow-Up Studies; Gastroscopes; Humans; Male; Middle Aged; Neoplasm Recurrence, Local; Palliative Care; Stents; Stomach; Stomach Neoplasms; Treatment Outcome

In recent years the implantation of self-expanding metal-stents has been recommended as a palliative kind of therapy for dysphagia caused by esophageal carcinoma. The metal-stent has a high flexibility, so that it can fit according to the preformed angel of the esophagocardial transition and does not cause a feeling of pressure when placed in the cervical position. From July 1992 to February 1995 in the surgical department of the University of Bonn 21 patients have got a self-expanding Nitinol stent. No dislocation, bleeding or perforation occurred. The dysphagia improved in all patients. The lethality rate was 9.5%, the mean survival rate 4,6 month. The growth of the tumor through the mesh of the stent was a problem which occurred from the tenth week onwards after implantation. Even when the self-expanding metal-stent does not solve all problems, it enlarges the spectrum of palliative kinds of therapy.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Female; Humans; Male; Middle Aged; Palliative Care; Prosthesis Design; Prosthesis Failure; Stents

Nitinol stents were used in ten patients as palliative treatment for carcinoma of the esophagus and the cardia. Following insertion of the stent the severity of dysphagia decreased on average from 3.2 to 1.5 (on a scale from 0-4). Difficulties with stent opening and passage through the gut were found particularly in the region of metal sutures at esophago-jejunal anastomoses. One stent, which had been obstructed by mucosal folds, had to be removed and replaced. One stent which had been incorrectly placed was extended by introducing a second stent by a coaxial technique. During the period of observation, six patients died after an average of 4.6 months. The palliative effect of the stent lasted on average for eleven weeks. In two patients the tumour grew beyond the stent and in three there was tumour growth into the stent.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Carcinoma, Squamous Cell; Cardia; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Palliative Care; Radiography; Stents; Stomach Neoplasms; Time Factors

Self-expanding metal stents have been recently used for the treatment of neoplastic esophageal stenoses. In our series, nitinol Strecker stents were implanted in ten patients with malignant esophageal intrinsic or extrinsic strictures, as a definitive palliation. Thirteen stents in all were used: two stents were positioned in three patients to recanalize the esophagus. The prostheses could always be inserted in the treated patients and in all of them swallowing was markedly improved. No major early complications were observed after stent insertion. All the stents but one were patent until the patient's death. Two patients are alive and bearing well-functioning stents. Self-expanding metal stents are to be preferred to plastic endoscopic tubes because their caliber is smaller at the time of insertion and they do not require general anesthesia, as endoscopic tubes sometimes require. Moreover, their complication rate is lower for both early and late complications. Tumor ingrowth through the stent mesh with stent occlusion is the major pitfall of these prostheses, together with the impossibility to use them when esophageal fistulas are present: these limitations will be soon overcome when silicone-coated expandable stents are on the market.

Topics: Aged; Aged, 80 and over; Alloys; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Esophagus; Female; Humans; Male; Middle Aged; Radiography, Interventional; Stents

A self-expanding esophageal nitinol stent was implanted under fluoroscopic guidance in 40 patients with malignant esophageal strictures and clinically significant dysphagia. The strictures were caused by squamous cell carcinoma (n = 14), adenocarcinoma (n = 12), recurrent anastomotic carcinoma (n = 8), and mediastinal tumors (n = 6). Eight stents were balloon dilated to maximum diameter immediately after insertion. Sixteen stents self-expanded to maximum diameter within 24 hours, and the other stents expanded to maximum diameter during further observation. There were no serious stent-related complications, and the dysphagia was reduced considerably in all patients immediately after stent insertion. Persistent tumor bleeding occurred in two patients, and ingrowth of tumor into the stent was seen in eight patients. Two stents occluded due to tumor ingrowth but were successfully recanalized with endoscopic laser coagulation. At the end of the study, 28 patients were dead with a mean survival of 2.9 months (range, 0.1-7.0 months), and 12 patients were alive with a mean follow-up of 8.8 months (range, 4.0-15.0 months).

Topics: Adult; Aged; Aged, 80 and over; Alloys; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Male; Mediastinal Neoplasms; Middle Aged; Palliative Care; Radiography, Interventional; Stents

Eight cases of benign esophageal stricture were treated with nickel titanium alloy stent, which was designed by the author since March 1992. The results were good except the three cases of long segment stenosis caused by chemical burn. The design of the stent and method of stent insertion was introduced in the paper. Also discussing the specialties of the nickel titanium alloy esophageal stent, especially it is easy to insert and easy to remove. The stent has no irritation to the esophageal mucosa. The stent could be used for the short segment of esophageal stricture safely, simply and effectively.

Topics: Adult; Aged; Alloys; Child, Preschool; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Nickel; Stents; Titanium

Nine patients (mean age 64, range 51-83 years), with dysphagia due to incurable malignant obstruction of the esophagus were treated by the introduction of 10 self-expanding metal endoprostheses (Nitinol stents). All cases were technically and functionally successful. In one patient the stent did not expand completely; it had to be removed and a second introduced. There were no other complications from the stent implantation. During the period of observation of 136 +/- 86 days one stent (11%) was reobstructed by tumor growing into the stent. Two patients died after 60 and 119 days, both with open stents. Early experience with the Nitinol stent indicates that good palliation of malignant dysphagia can be achieved with a much lower complication rate than results from tube implantation. The design and application system of the stent is capable of further improvement.

Topics: Aged; Alloys; Deglutition Disorders; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Esophagus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nickel; Pilot Projects; Radiography; Recurrence; Stents; Titanium

The authors present the case of an 81-year-old male patient with cardia adenocarcinoma. The patient underwent a surgical resection. Due to local recurrence Gianturco prosthesis implantation was performed. After 5 months of unimpeded swallowing, the patient gradually lost his ability to swallow. This was caused by tumor overgrowth. The serious condition was managed by nitinol (Ultraflex) metallic prosthesis. This reticular, compressed stent is a nickel-titanium based alloy. After implantation, as a result of the body temperature it assumes its original shape. After the twofold prosthesis implantation the patient had no complaints. The authors found the case worthy of presentation because of the new method and the originality of the new design.

Topics: Aged; Aged, 80 and over; Alloys; Esophageal Neoplasms; Esophageal Stenosis; Humans; Male; Neoplasm Recurrence, Local; Prostheses and Implants; Prosthesis Design; Radiography; Stents

The authors report their views on the treatment of unoperable neoplastic esophago-gastric stenoses with Nitinol prostheses. Despite a number of advantages (reduced trauma, greater tolerability) in relation to plastic prostheses, the paper highlights some problems (difficulty of unfastening, incomplete opening) which may be eliminated by improved materials.

Topics: Aged; Aged, 80 and over; Alloys; Esophageal Stenosis; Female; Humans; Male; Middle Aged; Prostheses and Implants

Topics: Aged; Alloys; Constriction, Pathologic; Dilatation; Esophageal Neoplasms; Esophageal Stenosis; Humans; Intestinal Obstruction; Male; Rectal Diseases; Rectal Neoplasms