UnknownNot Applicable

Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

South Korea54 participantsStarted 2019-02-15

Plain-language summary

The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.

Who can participate

Age range

19 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: * Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure Exclusion Criteria: * If endoscopy is not possible based on the judgement of the researcher * Life expectancy less than 6 months * Acute cholecystitis * Previous history of percutaneous transhepatic biliary drainage * Previous history of metal stent placement for malignant biliary stricture

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

Duration of stent patency

Timeframe: 9 months after randomization.

Trial details

NCT IDNCT03857958

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

Contact for this trial

Min su You, MD

82-2-2072-2228 bass105@hanmail.net

View on ClinicalTrials.gov More Malignant Hepatobiliary Neoplasm trials

Who can participate

Age range

19 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.