Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

NCT03857958 | Unknown

• 1 other identifier: 1812-098-996
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Hepatobiliary Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

FCSEMS

EXPERIMENTAL

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.

Procedure: endoscopic retrograde cholangio-pancreatography

Plastic stent

ACTIVE COMPARATOR

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.

Procedure: endoscopic retrograde cholangio-pancreatography

Interventions

endoscopic retrograde cholangio-pancreatography PROCEDURE

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.

Also known as: Plastic stent, FCSEMS

FCSEMS; Plastic stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Taewoong Medical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Study Officials

• Seoul National University Hospital Seoul National University Hospital, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min su You, MD

CONTACT

82-2-2072-2228; bass105@hanmail.net

Woo Hyun Paik, MD, PhD

CONTACT

82-2-2072-2228; whpaik@snuh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: February 28, 2019
• Study Start: February 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

KR (1)