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

Not Applicable

Recruiting

• Conditions: Malignant Biliary Obstruction
• Interventions: Device: uncovered self-expandable metal stent; Device: fully covered self-expandable metal stent with an anchoring external plastic stent

• Registration Number: NCT05220475
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2021-10-25
• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02
• Primary Completion: 2023-10-24
• Study Completion: 2024-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uc-SEMS	uncovered self-expandable metal stent	uncovered self-expandable metal stent
fc-SEMS with anchoring plastic stent	fully covered self-expandable metal stent with an anchoring external plastic stent	fully covered self-expanable metal stent with an external anchoring plastic stent

Primary Outcome Measures

Name	Time	Method
Rate of patent stent	1 year	The number of patient without stent dysfuction divided by total number of patients

Secondary Outcome Measures

Name	Time	Method
Stent migration	1 year	Radiologic finding of migration through Abdomen X-ray or CT scan
Stent obstruction	1 year	Suspected by jaundice (Total bilirubin \> 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP
Overall survival	1 year	Timespan from the diagnosis to the death
Re-intervention	1 year	Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage
Adverse event	1 year	acute cholangitis, acute cholecystitis, acute pancreatitis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of