12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Ob… (NCT07559968) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction
60 participantsStarted 2026-05
Plain-language summary
Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide evidence for selecting the most appropriate 12-mm metallic stent for patients with unresectable malignant distal 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:
* Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose, methods, and potential benefits and risks
* Adults aged 19 years or older
* Patients diagnosed with unresectable malignant distal biliary obstruction based on imaging studies (CT, MRI, ERCP, etc.) or histologic confirmation
* Patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract
Exclusion Criteria:
* Patients with a previous history of biliary metallic stent placement
* Patients with upper biliary obstruction (hilar level or above)
* Patients with other major biliary lesions in addition to malignant distal biliary obstruction
* Patients for whom the investigator judges that study conduct or data collection would be markedly difficult
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
1
Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure