Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

Not Applicable

• Conditions: Malignant Hepatobiliary Neoplasm

• Registration Number: NCT03857958
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.

Detailed Description

In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.

Study Timeline

• Study Start: 2019-02-15
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria

• If endoscopy is not possible based on the judgement of the researcher
• Life expectancy less than 6 months
• Acute cholecystitis
• Previous history of percutaneous transhepatic biliary drainage
• Previous history of metal stent placement for malignant biliary stricture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of stent patency	9 months after randomization.	The period from the insertion of the stent to the point at which stent revision is required.

Trial Locations

Locations (1)

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