Comparison of 12-mm Partial Covered and Bare Metallic Stents in Patients with Unresectable Malignant Distal Biliary Obstruction

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011921

Enrollment

Registered

2026-04-29

Start date

2026-05-15

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This study is a prospective, single-center, randomized clinical trial in patients with unresectable malignant distal biliary obstruction. After providing written informed consent and

Eligibility

Sex/Gender

All

Inclusion 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, Endoscopic Retrograde Cholangiopancreatography, (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

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

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure	—

Secondary

Measure	Time frame
Time to recurrent biliary obstruction (Time to RBO; stent patency duration);Overall rate of recurrent biliary obstruction (RBO);Causes of recurrent biliary obstruction (tumor ingrowth, tumor overgrowth, sludge, stent migration, etc.);Reintervention rate and number of reinterventions;Overall survival;Rate of procedure-related complications (pancreatitis, cholecystitis, bleeding, perforation, cholangitis, etc.)	—

Measure

Time frame

Time to recurrent biliary obstruction (Time to RBO; stent patency duration);Overall rate of recurrent biliary obstruction (RBO);Causes of recurrent biliary obstruction (tumor ingrowth, tumor overgrowth, sludge, stent migration, etc.);Reintervention rate and number of reinterventions;Overall survival;Rate of procedure-related complications (pancreatitis, cholecystitis, bleeding, perforation, cholangitis, etc.)

—

Countries

Korea, Republic of

Contacts

Public ContactWoosun Choi

Chung-Ang Univerisity Hospital

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

Outcome results