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 range

20 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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