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

NCT07559968 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

12-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.

DEVICE

12-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.

Sponsors & Collaborators

  • OSYMED CO., Ltd.

    collaborator UNKNOWN

  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    lead OTHER

Principal Investigators

  • Woosun Choi, MD, PhD · Associate Professor, Department of Radiology, Chung-Ang University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07559968 on ClinicalTrials.gov