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Anatomy-shaped design of a fully-covered, biliary, self-expandable metal stent for treatment of benign distal biliary strictures.

ABSTRACT: The treatment success of benign biliary strictures with fully covered metal stents (CSEMS) is altered by high stent dislocation rates. We aimed to evaluate a new stent design to prevent dislocation.Patients with benign biliary strictures were treated with a newly designed double-coned stent (dcSEMS). Mechanical analysis of the new stent was performed and it was compared with a cylindrical stent.A total of 13 dcCSEMS were implanted in 11 patients (2 female, 9 male, median age 47, range 33 - 71). All patients had distal biliary strictures due to chronic pancreatitis. No stent migration occurred. In all but one patient the stents were removed. One patient refused stent extraction and was lost to follow up. Stent occlusion occurred twice leading to cholangitis in both cases. The duration of stent treatment was 170 days (range 61 - 254). After extraction only one patient had early recurrent stricture and received the same stent again. Three stents showed minimal tissue granulation at the papilla. One stent presented ingrowth at the proximal end and was removed after implantation of a second fully covered stent. Mechanical examination revealed significantly lower radial expansion force of the new stent as compared to the cylindrical stent.The new stent design has a low rate of migration. Biomechanical properties may explain this effect.

SUBMITTER: Weigt J

PROVIDER: S-EPMC4713183 | biostudies-other | 2016 Jan

REPOSITORIES: biostudies-other

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Project description:AimTo compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor.MethodsWe performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included.ResultsThe analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19-4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05-10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57-1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94-1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56-0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12-0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03-3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54-34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36-4.50; p = 0.003, I2 = 0%).ConclusionsOur meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary obstruction due to their removability.

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Anatomy-shaped design of a fully-covered, biliary, self-expandable metal stent for treatment of benign distal biliary strictures.

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