Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

Not Applicable

• Conditions: Malignant Hepatobiliary Neoplasm
• Interventions: Procedure: endoscopic retrograde cholangio-pancreatography

• 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

Arm && Interventions

Group	Intervention	Description
FCSEMS	endoscopic retrograde cholangio-pancreatography	In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography.
Plastic stent	endoscopic retrograde cholangio-pancreatography	In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture.

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