12-mm Partially Covered vs Bare Self-Expandable Stents for Malignant Distal Biliary Obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized trial compares two 12-mm self-expandable metallic stents in adults with unresectable malignant distal biliary obstruction who have undergone PTBD. Participants are randomly assigned to receive either a partially covered or a bare stent through the existing PTBD tract and are followed for 12 months with assessments at 3, 6, and 12 months. Outcomes include recurrent biliary obstruction, stent patency, need for reintervention, overall survival, and procedure-related complications. The study aims to provide evidence to guide selection of the more effective and safe 12-mm stent type in this palliative setting. It is a single-center trial sponsored by Chung-Ang University Hospital with collaboration from OSYMED Co., Ltd.

Why it matters

Who can join: the full rules

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

Where it's running

• Chung-Ang university Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Woosun Choi, MD, PhD — Associate Professor, Department of Radiology, Chung-Ang University Hospital
• Study coordinator: Woosun Choi, MD, PhD
• Email: radiochoi527@gmail.com
• Phone: +82-2-6299-2681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.