nitinol and Adenocarcinoma

The recent development of a compression device using shape memory Nitinol technology to create an end-to-end anastomosis has renewed the interest in sutureless anastomotic techniques. A phase II, prospective open label clinical trial was started in May 2007 to evaluate the feasibility and safety of this new anastomotic device. Fourty patients who need left colectomy or high anterior resection for either diverticular disease or adenocarcinoma will be recruited in two academic hospitals (Uppsala,Sweden and Leuven, Belgium). Clinical leakage is the primary endpoint. Only preliminary results are available to date as the recruitment is ongoing. The median age of the first ten patients is 57.5 years (44-72). No anastomotic leakage occurred. The median hospital stay was 4.0 days. Only three patients noticed the passage of the ring through the anal canal. By three weeks no ring was sustained in the gastrointestinal tract as was objectified by plain X-ray. First clinical use of this new anastomotic device seems promising. Final results for the total phase II trial are awaited. A prospective randomized trial to compare the efficacy of the EndoCar 28 with conventional stapling should be the next step.

Topics: Adenocarcinoma; Adult; Aged; Alloys; Anastomosis, Surgical; Animals; Colectomy; Colon; Digestive System Surgical Procedures; Diverticulosis, Colonic; Elasticity; Humans; Length of Stay; Middle Aged; Pilot Projects; Pressure; Prospective Studies; Rectum; Suture Techniques

Emergency surgery for malignant colon obstruction entails relatively high morbidity and mortality rates and typically necessitates a 2-step resection. These problems might be potentially mitigated by placement of a self-expanding metal stent (SEMS) as a bridge to surgery. A nitinol colorectal SEMS may offer several advantages, but available evidence on the utility of this SEMS type remains highly limited.. Our purpose was to evaluate the effectiveness and safety as a bridge to surgery of a nitinol SEMS designed for colorectal use.. Prospective and retrospective multicenter clinical study.. Sixteen European study centers.. Thirty-six patients with malignant colonic obstruction.. Nitinol colorectal SEMS placement.. Technical success in accurate SEMS placement with coverage of the entire stricture length, clinical success in alleviating colonic obstructive symptoms, and bridging to elective surgery.. Technical success was achieved in 97% of patients with a 95% CI of 85% to 100% and clinical success in 81% (95% CI, 64%-92%). Elective surgery was performed in 94% (95% CI, 81%-99%) of patients at a median of 11 days (95% CI, 7-15 days) after SEMS placement. SEMS-related perforation occurred in 3 patients.. No control group was included in this nonrandomized cohort study.. In this first comparatively large clinical study of a nitinol colorectal SEMS as a bridge to surgery, a high proportion of patients successfully proceeded to elective surgery after prior decompression by SEMS placement.

Topics: Adenocarcinoma; Adult; Alloys; Colonic Neoplasms; Decompression, Surgical; Duodenal Diseases; Female; Humans; Intestinal Obstruction; Male; Prospective Studies; Prosthesis Design; Prosthesis Implantation; Retrospective Studies; Stents

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

Self-expandable metallic stents (SEMS) of varying designs and materials have been developed to reduce complications, but few comparative data are available with regard to the type of stent and the stent manufacturer. We analyzed the success rates and complication rates, according to stent type (uncovered vs. covered stent) and individual stent manufacturer, in malignant colorectal obstruction.. From November 2001 to August 2008, 103 patients were retrospectively included in this study: four types of uncovered stents in 73 patients and two types of covered stents in 30 patients. The SEMS was inserted into the obstructive site by using the through-the-scope method.. Technical and clinical success rates were not different between stent type or among stent manufacturers: 100 and 100% (p = ns) and 100 and 96.6% (p > 0.05), respectively, in uncovered and covered stents. Stent occlusion and migration rates were 12.3 and 3.3% (p = 0.274) and 13.7 and 16.7% (p = 0.761), respectively, in uncovered and covered stents, and 11.1, 5, and 9% (p = 0.761) and 25.9, 15, and 0% (p = 0.037) in Wallstent, Niti-S, and Bonastent uncovered stents, respectively.. The placement of SEMS is an effective and safe treatment for patients with malignant colorectal obstruction. Although minor differences in outcome were detected according to the type and the manufacturer of the stents, no statistically significant difference was observed, except in stent migration among the stent manufacturer.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Carcinoma; Chromium Alloys; Coated Materials, Biocompatible; Cobalt; Colonic Diseases; Colonic Neoplasms; Colonoscopy; Equipment Design; Female; Fluoroscopy; Foreign-Body Migration; Humans; Intestinal Obstruction; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Radiography, Interventional; Rectal Diseases; Stents; Stomach Neoplasms; Treatment Outcome; Uterine Cervical Neoplasms

Self-expanding metal stents (SEMSs) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. The use of colonic larger-diameter SEMSs may improve bowel function and reduce migration risk.. To evaluate the effectiveness and safety of a novel large-diameter SEMS (WallFlex) designed for delivery through the endoscope in treating malignant colonic obstruction.. Prospective clinical cohort study.. Two Italian study centers.. Forty-two consecutive patients with malignant colonic obstruction: 23 requiring palliation and 19 bridging to surgery.. Colorectal SEMS placement.. Technical success, defined as accurate SEMS deployment across the stricture on the first attempt; clinical success, ie, complete relief of bowel obstruction without complications; and bridging to surgery, denoting the performance of elective one-stage surgery.. The rate of technical success was 93% (95% CI, 81%-99%) and of initial clinical success was 95% (95% CI, 84%-99%). In 58% (95% CI, 40%-84%) of the palliation group, clinical success was maintained after 6 months. All 19 patients with operable tumors were successfully bridged to one-stage elective surgery within a median of 5 days. One perforation and one stent migration occurred. All complications could be resolved nonsurgically.. No control group was included.. In a prospective study of through-the-scope WallFlex stent placement for malignant colonic obstruction, high rates of technical and initial clinical success, and bridging to surgery were achieved. Complications could be readily managed.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Colon, Sigmoid; Colonic Neoplasms; Constriction, Pathologic; Female; Humans; Intestinal Obstruction; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sigmoid Diseases; Stents

The endoscopic placement of metallic stents for palliation of malignant obstruction of the GI or biliary tract is an established practice and as such is often applied. Use of these stents, however, has its problems. Stent migration may cause obstruction of the bowel lumen. Migration of a biliary stent into the contralateral duodenal wall may cause difficulty in gaining access to the biliary tract, as will the placement of a duodenal stent across the ampulla.. We report on 6 patients in whom trimming of the metallic nitinol stent was performed.. Single-center, retrospective case series.. Secondary referral center.. Of 6 patients included, 2 patients each had an uncovered duodenal stent, 2 had an uncovered biliary stent each, 1 had an uncovered colorectal stent, and 1 had a covered gastroduodenal stent.. Under direct endoscopic vision, an argon plasma beam was used to cut self-expandable metallic stents, as appropriate.. The main objective was relief of the obstruction to the bowel lumen or bile duct, facilitating successful passage of an endoscope or biliary canulation, respectively.. In all 5 patients with uncovered metallic stents, we were able to re-establish access to the obstructed bowel lumen or the biliary tree, as indicated. An attempt to tailor the length of a covered metallic gastroduodenal stent failed. No complications were observed and no hemorrhage or perforation occurred.. The study was limited by retrospective design and small sample size.. The endoscopic cutting and tailoring of an uncovered metallic prosthesis, by means of an argon plasma beam, is feasible, effective, and safe. Trimming of covered stents is not advocated.

Topics: Adenocarcinoma; Aged; Alloys; Argon; Biliary Tract Neoplasms; Device Removal; Electrosurgery; Endoscopy, Gastrointestinal; Female; Foreign-Body Migration; Humans; Intestinal Obstruction; Male; Middle Aged; Pancreatic Neoplasms; Stents

The author reports successful outcomes after percutaneous transhepatic placement of covered, self-expandable nitinol stents in two patients who had afferent loop syndrome caused by recurrent gastric carcinoma. A 46-year-old woman and a 60-year-old man who had undergone subtotal gastrectomy and gastrojejunostomy (Billroth II) were both admitted with symptoms of afferent loop syndrome. In each patient, enhanced abdominal computed tomography showed marked dilation of the jejunal limb and intrahepatic bile ducts incident to recurrent gastric carcinoma. Percutaneous transhepatic biliary drainage was successfully performed, and a multi-sidehole drainage catheter was placed beyond the papilla of Vater. Successful palliation of the afferent loop obstruction was achieved by placing a covered, self-expandable nitinol stent through the transhepatic biliary drainage route. There were no procedure-related complications, and both patients showed clinical improvement.

Topics: Adenocarcinoma; Afferent Loop Syndrome; Alloys; Carcinoma, Signet Ring Cell; Catheterization; Fatal Outcome; Female; Gastrectomy; Hepatic Artery; Humans; Jejunostomy; Male; Middle Aged; Neoplasm Recurrence, Local; Prosthesis Implantation; Stents; Stomach Neoplasms

The use of self-expanding metallic stents (SEMS) as esophageal endoprosthesis represents an advancement in the palliation of dysphagia from unresectable esophageal carcinoma. However, the problem of stent migration persists. Although most migrated stents have a benign outcome, complications do occur. Rare reports of intestinal obstruction have been confined to the stiff plastic and stainless-steel stents. We report the first case of intestinal obstruction secondary to the pliable Nitinol SEMS (Ultraflex) migration.

Topics: Adenocarcinoma; Aged; Alloys; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Deglutition Disorders; Device Removal; Epirubicin; Equipment Design; Esophageal Neoplasms; Fluorouracil; Foreign-Body Migration; Humans; Ileal Diseases; Intestinal Obstruction; Laparotomy; Liver Neoplasms; Male; Postoperative Complications; Stents

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

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

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

Topics: Adenocarcinoma; Alloys; Endoscopes; Equipment Failure; Esophageal Neoplasms; Esophagoscopes; Esophagoscopy; Fatal Outcome; Humans; Male; Middle Aged; Palliative Care; 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

The authors implanted a duodenal stent in a woman with a high-grade duodenal stenosis due to inoperable tumor compression. A flexible self-expanding knitted nitinol stent that conformed to the shape of the duodenum was introduced orally to keep the duodenal passage patent. After stent implantation, repeated vomiting stopped and the patient was able to eat and drink. This technique resolved the patient's duodenal stenosis.

Topics: Adenocarcinoma; Alloys; Colonic Neoplasms; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Female; Humans; Middle Aged; Palliative Care; Radiography, Interventional; Stents

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

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