Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

Seoul National University

Status: Unknown

Conditions: Malignant Hepatobiliary Neoplasm

Treatments: Procedure: endoscopic retrograde cholangio-pancreatography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03857958

1812-098-996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

FCSEMS

Experimental group

Description:

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.

Treatment:

Procedure: endoscopic retrograde cholangio-pancreatography

Plastic stent

Active Comparator group

Description:

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.

Treatment:

Procedure: endoscopic retrograde cholangio-pancreatography