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

NCT03279809 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Biliary Stasis, Extrahepatic

Interventions

DRUG

Aspirin

Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction

DRUG

Placebo

Case with placebo medication for 6 months after stenting

Sponsors & Collaborators

  • Woo Hyun Paik

    lead OTHER

Principal Investigators

  • Woo Hyun Paik, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2020-09-05
Completion
2020-09-05

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03279809 on ClinicalTrials.gov