NCT07559968 12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction
| NCT ID | NCT07559968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chung-Ang University Hospital |
| Condition | Malignant Distal Biliary Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-05-27 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Woosun Choi, MD, PhD
PRINCIPAL INVESTIGATOR
Associate Professor, Department of Radiology, Chung-Ang University Hospital
Frequently Asked Questions
Who can join the NCT07559968 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Malignant Distal Biliary Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07559968 currently recruiting?
Yes, NCT07559968 is actively recruiting participants. Contact the research team at radiochoi527@gmail.com for enrollment information.
Where is the NCT07559968 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07559968 clinical trial?
NCT07559968 is sponsored by Chung-Ang University Hospital. The principal investigator is Woosun Choi, MD, PhD at Associate Professor, Department of Radiology, Chung-Ang University Hospital. The trial plans to enroll 60 participants.