nitinol and Digestive-System-Neoplasms

To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.. After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.. Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6).. In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Belgium; Cholestasis; Coated Materials, Biocompatible; Digestive System Neoplasms; Drainage; Female; Humans; Male; Middle Aged; Palliative Care; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Young Adult

To prospectively evaluate safety and efficacy of biliary stent placement with iodine-125 (. From July 2011 to June 2014, 55 patients were enrolled (group A, 11 men and 17 women, mean age 70.93 y ± 8.58; group B, 14 men and 13 women, mean age 70.26 y ± 9.71). All patients were randomly assigned to placement of a biliary stent with. Stents were successfully placed in all 55 patients. MOJ was relieved in all patients, and there were no significant differences in complications related to stent insertion between the 2 groups. Mean and median stent patency were 191 days ± 19.8 (95% confidence interval [CI], 152-230 d) and 179 days ± 191.4 (95% CI, 87-267 d) in group A and 88.3 days ± 16.3 (95% CI, 61-114 d) and 77 days ± 88.2 (95% CI, 65-86 d) in group B (P < .001, log-rank test). Mean and median survival time were 222.6 days ± 21.0 (95% CI, 181-263 d) and 241 days ± 18.2 (95% CI, 179-270 d) in group A and 139.1 days ± 14.5 (95% CI, 110-167 d) and 142 days ± 16.3 (95% CI, 83-177 d) in group B (P < .001, log-rank test).

Topics: Aged; Aged, 80 and over; Alloys; Brachytherapy; China; Cholestasis; Digestive System Neoplasms; Female; Humans; Iodine Radioisotopes; Jaundice, Obstructive; Kaplan-Meier Estimate; Male; Middle Aged; Positron Emission Tomography Computed Tomography; Prospective Studies; Radiography, Interventional; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction.. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups.. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016).. The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Digestive System Neoplasms; Duodenal Obstruction; Female; Gastric Outlet Obstruction; Humans; Male; Middle Aged; Palliative Care; Prospective Studies; Prosthesis Failure; Retreatment; Single-Blind Method; Stents

Stent migration occurs frequently, but the prevention of complications resulting from covered self-expandable metal stents (C-SEMSs) remains unresolved. We prospectively assessed a newly developed C-SEMS, a modified covered Zeo stent (m-CZS), in terms of its antimigration effect.. Between February 2010 and January 2011, an m-CZS was inserted into 42 patients (31 initial drainage cases and 11 reintervention cases) at a tertiary referral center and three affiliated hospitals. The laser-cut stent was flared for 1.5 cm at both ends, with a 1 cm raised bank located 1 cm in from each flared end. The main outcome of this study was the rate of stent migration, and secondary outcomes were the rate of recurrent biliary obstruction (RBO), the time to RBO, the frequencies of complications, and overall survival.. Of the 31 patients with initial drainage, stent migration occurred in four (12.9%, 95% confidence interval, 5.1% to 29.0%), with a mean time of 131 days. RBO occurred in 18 (58%), with a median time to RBO of 107 days. Following previous C-SEMS migration, seven of 10 patients (70%) did not experience m-CZS migration until death.. m-CZSs with antimigration properties effectively, although not completely, prevented stent migration after stent insertion.

Topics: Aged; Aged, 80 and over; Alloys; Carcinoma; Cholestasis; Digestive System Neoplasms; Drainage; Equipment Design; Feasibility Studies; Female; Humans; Kaplan-Meier Estimate; Lymphatic Metastasis; Male; Middle Aged; Prosthesis Failure; Recurrence; Reoperation; Stents; Time Factors

The covered metallic stent is effective for managing malignant distal biliary obstructions. The most popular covered metallic stent is the covered Wallstent (CWS). This study estimated the efficacy and safety of a new expanded polytetrafluoroethylene (e-PTFE)-covered nitinol metallic stent, the ComVi stent. This covered metallic stent consists of an e-PTFE membrane sandwiched between two uncovered metallic stents with weak axial (straightening) force. Wire is exposed on both the inner and outer surfaces.. Between May 2005 and April 2007, ComVi stents were placed consecutively in 47 patients with unresectable malignant distal biliary obstruction. The cases involved 35 pancreatic cancers, 8 metastatic nodes, 2 gallbladder cancers, and 2 bile duct cancers. The patients were compared with 47 patients who received CWS placement between August 2001 and May 2005 matched for age, sex, and causative disease from 133 cases.. No significant differences in stent patency or patient survival were found. Stent occlusion was observed in 13 patients (27.7%) in the ComVi group and 10 patients (21.3%) in the CWS group. The cause of occlusion in both groups was tumor overgrowth (4.25% vs 4.2%), sludge (8.5% vs 6.3%), impaction of food scraps (14.9% vs 2.1%), and bile duct kinking (0% vs 8.4%). Other complications were migration (2.1% vs 17.0%; p = 0.0304) and cholecystitis (2.1% vs 6.3%), and there were significant differences in the incidence of complications except for occlusion (4.2% vs 24.6%; p = 0.0142).. The ComVi stent has a patency similar to that of the CWS and a lower incidence of migration. However, early occlusion by food impaction was increased and should be resolved.

Topics: Aged; Alloys; Cholestasis, Extrahepatic; Coated Materials, Biocompatible; Digestive System Neoplasms; Female; Humans; Male; Middle Aged; Polytetrafluoroethylene; Prospective Studies; Prosthesis Implantation; Stents

To determine the safety and efficacy of endoscopic duodenal stent placement in patients with malignant gastric outlet obstruction.. This prospective, observational, multicenter study included 39 consecutive patients with malignant gastric outlet obstruction. All patients underwent endoscopic placement of a nitinol, uncovered, self-expandable metal stent. The primary outcome was clinical success at 2 wk after stent placement that was defined as improvement in the Gastric Outlet Obstruction Scoring System score relative to the baseline.. Technical success was achieved in all duodenal stent procedures. Procedure-related complications occurred in 4 patients (10.3%) in the form of mild pneumonitis. No other morbidities or mortalities were observed. The clinical success rate was 92.3%. The mean survival period after stent placement was 103 d. The mean period of stent patency was 149 d and the patency remained acceptable for the survival period. Stent dysfunction occurred in 3 patients (7.7%) on account of tumor growth.. Endoscopic management using duodenal stents for patients with incurable malignant gastric outlet obstruction is safe and improved patients' quality of life.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Digestive System Neoplasms; Duodenoscopes; Duodenoscopy; Female; Gastric Outlet Obstruction; Humans; Japan; Male; Middle Aged; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome

The usefulness of bilateral stent placement for malignant hilar obstruction is still under debate. Nevertheless, many endoscopists advocate the placement of an endoscopic bilateral metal stent using various new devices and techniques.. We compared the technical and clinical efficacy, and the short-term and long-term complications of the 'stent-in-stent' method using a Y-stent for malignant hilar obstruction between the early and the late period of this study.. Ninety-seven patients treated with Y-stent implantation for malignant hilar obstruction were enrolled retrospectively. In 31 patients treated during the early period, bilateral Y-configured metal stents were placed for malignant hilar obstruction using the older designed Y-stent and a closed-cell second stent. The newly designed Y-stent and a slimmer open-cell second stent were introduced in 66 patients treated during the late period. New techniques learned through experience were gradually applied throughout the entire study period.. The rate of successful placement of bilateral stents was significantly higher in patients treated during the late period than those treated during the early period (58.1 vs. 87%; P=0.001). The functional success rate was 97.3%, with no difference between the early and the late periods. Cholangitis occurred as an early complication more frequently during the early period than during the late period (16.1 vs. 1.5%; P=0.012). Cholecystitis as a late complication occurred in 21 of 76 patients (27.6%). The incidence of late complications was similar between the early and the late periods.. With the development of new devices and increased technical experience, there were better outcomes during the late period compared with the early period. Endoscopic bilateral metal stenting using a Y-stent is an attractive option for the palliative treatment of malignant hilar obstruction.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Chi-Square Distribution; Cholangiopancreatography, Endoscopic Retrograde; Cholangitis; Cholecystitis; Cholestasis; Digestive System Neoplasms; Drainage; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Palliative Care; Prosthesis Design; Republic of Korea; Retrospective Studies; Sphincterotomy, Endoscopic; Stents; Time Factors; Treatment Outcome

Gastric outlet obstruction (GOO) is a late complication of advanced gastric, periampullary, and duodenal malignancies. Palliation of obstruction is the primary aim of treatment in these patients. Self-expandable metal stents have emerged as a promising treatment option. Our aim was to investigate the safety and efficacy of a new non-foreshortening nitinol duodenal stent.. A total of 52 patients with symptomatic malignant GOO were studied in this prospective multicenter cohort study. All patients received a D-Weave Niti-S duodenal stent (Taewoong Medical, Seoul, South Korea). Patients were followed up until withdrawal of informed consent or death.. The cause of GOO was pancreatic cancer in the majority of patients (62%). The technical and clinical success rates were 96% and 77%, respectively. The GOO Scoring System score improved significantly (P < 0.0001) when the scores before stenting were compared with the mean scores until death. Median survival was 82 days and stent patency was observed in 75% for up to 190 days, accounting for death as a competing risk. In 13 patients (25%) stent dysfunction occurred (tumor ingrowth in 11, stent migration in two). Over time, the body mass index, the World Health Organization performance score, and the EuroQol visual analog scale revealed a not significant change (P = 0.52, P = 0.43, and P = 0.15, respectively), whereas the global health status improved significantly (P = 0.001).. Placement of a new non-foreshortening nitinol enteral stent is safe and without major complications. This stent design produces significant relief of obstructive symptoms and improves quality of life in patients with incurable malignant GOO.

Topics: Aged; Alloys; Digestive System Neoplasms; Female; Gastric Outlet Obstruction; Humans; Male; Middle Aged; Palliative Care; Prospective Studies; Prosthesis Failure; Quality of Life; Statistics, Nonparametric; Stents