Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in South Korea / NCT07559968
Recruiting Not applicable

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

NCT07559968 · tracked via the Priya Life Science South Korea tracker
Sponsor
Chung-Ang University Hospital
Phase
Not applicable
Started
2026-05-27
Last updated
2026-07-13

Condition(s) studied

Malignant Distal Biliary ObstructionMalignant Biliary ObstructionBiliary Obstruction

Investigational drug(s) / intervention(s)

12-mm partially covered self-expandable metallic stent12-mm bare self-expandable metallic stent

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.

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.

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure — 12 months after the procedure
    Cumulative incidence of recurrent biliary obstruction related to the initially inserted study stent (index stent).

Trial sites (1)

FacilityCityRegionStatus
Chung-Ang university Hospital Seoul Seoul Recruiting

More Chung-Ang University Hospital trials in South Korea

Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment Recruiting
Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF) Enrolling by invitation

Other trials for the same condition

Prevention of Acute Cholecystitis With ETGBD Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07559968 on ClinicalTrials.gov ↗ ← All trials in South Korea