A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

Seoul National University

Status: Enrolling

Conditions: Malignant Biliary Obstruction

Treatments: Device: uncovered self-expandable metal stent; Device: fully covered self-expandable metal stent with an anchoring external plastic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05220475

H-2012-043-1179

Details and patient eligibility

About

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Full description

This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Enrollment: 108 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with 19 years of age or older
• Those who voluntarily consented to the trial and signed a written consent
• Inoperable malignant biliary obstruction

Exclusion criteria

• Previous surgical biliary drainage
• Patients continuosly requiring percutaneous transhepatic biliary drainage
• History of biliary drainage with metal stent
• Biliary obstruction located in hilum or intrahepatic duct
• Patients with life expectancy of 3 months or less
• On pregnancy
• Unable to underwent endoscopic procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

fc-SEMS with anchoring plastic stent

Experimental group

Description:

fully covered self-expanable metal stent with an external anchoring plastic stent

Treatment:

Device: fully covered self-expandable metal stent with an anchoring external plastic stent

uc-SEMS

Active Comparator group

Description:

uncovered self-expandable metal stent

Treatment:

Device: uncovered self-expandable metal stent