RecruitingNot ApplicableNCT07559968

12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction

12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction: A Prospective, Randomized Clinical Study

Sponsor

Chung-Ang University Hospital

Enrollment

60 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

Malignant Biliary Obstruction Biliary Obstruction Malignant Distal Biliary Obstruction

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

Min Age: 19 Years

Inclusion Criteria4

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 Criteria4

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

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Interventions

DEVICE12-mm partially covered self-expandable metallic stent

A 12-mm partially covered self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.

DEVICE12-mm bare self-expandable metallic stent

A 12-mm bare self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.