CompletedNot Applicable

The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent

South Korea70 participantsStarted 2018-02-26

Plain-language summary

The aim of this study is to demonstrate that the group with an additional plastic stent to anchor the fully covered self expandable metal stent (FCSEMS) in patients with malignant biliary stricture has less stent migration than the group with FCSEMS only. The primary outcome is stent migration for 6 months. The secondary outcomes are stent related adverse events, stent patency, and overall survival.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Malignant biliary stricture requiring biliary drainage through endoscopic procedure Exclusion Criteria: * Previous history of metal stent placement for malignant biliary stricture * Hilar cholangiocarcinoma * Malignant biliary stricture of intrahepatic duct * A recurrence after surgery due to malignant biliary stricture * Life expectancy less than 3 months * Pregnancy * If endoscopy is not possible based on the judgement of the researcher

What they're measuring

Stent migration rate

Timeframe: 6 months after randomization

Trial details

NCT IDNCT03439020

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-31

View on ClinicalTrials.gov More Malignant Biliary Stricture trials