Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

Malignant Hepatobiliary Neoplasm Clinical Trial

Official title:

Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857958
• Other study ID #: 1812-098-996
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: Min su You, MD
• Phone: 82-2-2072-2228
• Email: bass105[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Hepatobiliary Neoplasm

Intervention

Procedure:
• endoscopic retrograde cholangio-pancreatography
In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of stent patency	The period from the insertion of the stent to the point at which stent revision is required.	9 months after randomization.