NCT05220475

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

A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Malignant Biliary Obstruction

Interventions

Type	Name	Description
DEVICE	fully covered self-expandable metal stent with an anchoring external plastic stent	Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
DEVICE	uncovered self-expandable metal stent	Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent

Timeline

• Start date: 2021-10-25
• Primary completion: 2023-10-24
• Completion: 2024-10-24
• First posted: 2022-02-02
• Last updated: 2022-02-02

Locations

1 site across 1 country: South Korea