nitinol and Esophageal-Fistula

This paper reports our experience with a new over-the-scope clip in the setting of recurrent bleeding and oesophageal fistula. We treated five patients with the over-the-scope Padlock Clip™. It is a nitinol ring, with six inner needles preassembled on an applicator cap, thumb press displaced by the Lock-It™ delivery system. The trigger wire is located alongside the shaft of the endoscope, and does not require the working channel. Three patients had recurrent bleeding lesions (bleeding rectal ulcer, post polypectomy delayed bleeding and duodenal Dieulafoy's lesion) and two patients had a persistent respiratory-esophageal fistula. In all patients a previous endoscopic attempt with standard techniques had been useless. All procedures were conducted under conscious sedation but for one patient that required general anaesthesia due to multiple comorbidities. We used one Padlock Clip™ for each patient in a single session. Simple suction was enough in all of our patients to obtain tissue adhesion to the instrument tip. A remarkably short application time was recorded for all cases (mean duration of the procedure: 8 min). We obtained technical and immediate clinical success for every patient. No major immediate, early or late (within 24 h, 7 d or 4 wk) adverse events were observed, over follow-up durations lasting a mean of 109.4 d. One patient, treated for duodenal bulb bleeding from a Dieulafoy's lesion, developed signs of mild pancreatitis 24 h after the procedure. The new over-the-scope Padlock Clip™ seems to be simple to use and effective in different clinical settings, particularly in "difficult" scenarios, like recurrent bleeding and respiratory-oesophageal fistulas.

Topics: Aged; Aged, 80 and over; Alloys; Equipment Design; Esophageal Fistula; Esophagoscopes; Esophagoscopy; Gastrointestinal Hemorrhage; Humans; Male; Middle Aged; Operative Time; Postoperative Complications; Surgical Instruments; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

Topics: Alloys; Anastomosis, Surgical; Esophageal Fistula; Esophagus; Gastroscopy; Humans; Male; Middle Aged; Postoperative Complications; Prostheses and Implants; Reoperation; Stents; Stomach; Stomach Neoplasms; Surgical Instruments; Sutures

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

To assess the efficacy and safety of covered retrievable nitinol stents in oesophageal cancer patients with airway involvement.. Under fluoroscopic guidance, covered retrievable nitinol airway stents were placed in 23 oesophageal cancer patients with airway stricture and/or oesophagorespiratory fistula (ERF) over a long period of 12 years. Six patients only had aspiration by ERF and three patients had both airway stricture and asymptomatic ERF. Technical aspects, dyspnoea improvement, and/or resolution of ERF symptoms, complications, reinterventions, and survival data were evaluated.. A total of 27 airway stents (14 tracheal, 11 bronchial, and two hinged) were placed successfully in 23 patients with airway stricture or ERF. Dyspnoea score decreased significantly after stent placement (p<0.001). ERF were sealed off in all nine patients. Complications included stent migration or expectoration (n=4), haemoptysis (n=2), sputum retention (n=7), and tumour overgrowth (n=1). All three migrated stents were easily removed. Twenty-one patients died, with the median survival period of 76 days (range 2-197 days).. Placement of covered retrievable expandable nitinol stents was safe and effective for the palliative treatment of airway strictures and/or ERF, with a reasonable range of complications, in patients with advanced oesophageal cancer.

Topics: Adult; Aged; Airway Obstruction; Alloys; Bronchi; Bronchography; Device Removal; Epidemiologic Methods; Esophageal Fistula; Esophageal Neoplasms; Female; Fluoroscopy; Foreign-Body Migration; Humans; Male; Middle Aged; Neoplasm Invasiveness; Palliative Care; Radiography, Interventional; Respiratory Tract Fistula; Stents; Tracheal Stenosis; Treatment Outcome

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

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

Three models of covered metal stents are available to seal esophageal fistulas.. Stainless steel covered stents were inserted in 5 patients (group I); nitinol covered stents were inserted in 12 patients (group II) with malignant (n = 14) or benign (n = 3) esophageal fistulas.. Stent positioning was satisfactory in all cases. Fistula sealing was complete in 1 of 5 (20%) and 12 of 12 (100%) patients of groups I and II, respectively (p < 0.005). Continued esophageal leakage was initially related to the passage of fluids alongside the stent covering (n = 3) and to early stent migration (n = 1). Complications related to stent placement were observed in 2 of 17 (12%) patients and were fatal. During follow-up (mean 153 +/- 143 days), esophageal fistulas relapsed after initial sealing in 5 of 13 (38%) patients. Further treatment (glue or fibrin sealant injection, additional stent insertion) was attempted in 7 cases of persistent or relapsing esophageal fistula, with sealing obtained in 5 of them. The costs per patient and per day free from symptoms due to the esophageal fistula were $106 and $57 in groups I and II, respectively.. Nitinol covered stents more frequently provided complete esophageal fistula sealing, as compared with stainless steel covered stents. Further treatments tailored to the mechanisms of fistula persistence or relapse often provided sealing.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Biocompatible Materials; Child; Costs and Cost Analysis; Endoscopes; Endoscopy; Endoscopy, Digestive System; Esophageal Fistula; Female; Follow-Up Studies; Humans; Length of Stay; Male; Middle Aged; Prospective Studies; Prosthesis Design; Prosthesis Failure; Radiography; Stainless Steel; Stents

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