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

NCT07559968 | Not Yet Recruiting

• 1 other identifier: 2603-004-677
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Distal Biliary Obstruction; Malignant Biliary Obstruction; Biliary Obstruction

Keywords

12-mm metallic stent; partially covered self-expandable metallic stent; bare self-expandable metallic stent; malignant distal biliary obstruction; PTBD; recurrent biliary obstruction; stent patency

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure

  Cumulative incidence of recurrent biliary obstruction related to the initially inserted study stent (index stent).

  12 months after the procedure

Secondary Outcomes (7)

• Time to recurrent biliary obstruction (Time to RBO; stent patency duration)

  Up to 12 months after the procedure

• Overall rate of recurrent biliary obstruction (RBO)

  Up to 12 months after the procedure

• Number of participants by cause of recurrent biliary obstruction

  Up to 12 months after the procedure

• Rate of reintervention

  Up to 12 months after the procedure

• Number of reinterventions

  Up to 12 months after the procedure

Study Arms (2)

12-mm Partially Covered SEMS Group

EXPERIMENTAL

Participants in this arm will receive a 12-mm partially covered self-expandable metallic stent (ComVi Biliary Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction.

Device: 12-mm partially covered self-expandable metallic stent

12-mm Bare SEMS Group

ACTIVE COMPARATOR

Participants in this arm will receive a 12-mm bare self-expandable metallic stent (Niti-S Biliary Uncovered Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction.

Device: 12-mm bare self-expandable metallic stent

Interventions

12-mm partially covered self-expandable metallic stent DEVICE

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.

12-mm Partially Covered SEMS Group

12-mm bare self-expandable metallic stent DEVICE

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.

12-mm Bare SEMS Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead
• OSYMED CO., Ltd.: collaborator

Study Officials

• Woosun Choi, MD, PhD

  Associate Professor, Department of Radiology, Chung-Ang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woosun Choi, MD, PhD

CONTACT

+82-2-6299-2681; radiochoi527@gmail.com

Jinyoung Choi, MD

CONTACT

+82-2-6299-2681; hananox@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the type of stent inserted, whereas treating investigators will not be masked because they perform the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Radiology, Chung-Ang University Hospital

Model Details: Participants will be randomly assigned in a 1:1 ratio to two parallel groups receiving either a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share