TerminatedNot Applicable

The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction

Stopped: One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs

South Korea52 participantsStarted 2017-10-12

Plain-language summary

The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered and its maintenance period has been reported to be about 8 months. This study will be prospectively conducted as a randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. The primary endpoint is the incidence of stent dysfunction in both groups for 6 months after the procedure. The secondary endpoints included duration of metallic stent patency, incidence of further procedures, and adverse events related with aspirin.

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 distal bile duct obstruction * Over 20 years old * Techinical success of endoscopic retrograde biliary drainage with metalic stent Exclusion Criteria: * Patient's denial * Previous Aspirin use * Aspirin allergy * Contraindication for aspirin * Life expectancy \< 6mo * Gastroduodenal ulcer * History of substance abuse * Participation in a clinical trial within the past 30 days

What they're measuring

Incidence of stent dysfunction

Timeframe: 6 months after biliary metalic stent

Trial details

NCT IDNCT03279809

SponsorWoo Hyun Paik

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-05

View on ClinicalTrials.gov More Biliary Stasis, Extrahepatic trials