Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Hepatobiliary Neoplasm
• Intervention / Treatment: Procedure: endoscopic retrograde cholangio-pancreatography

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 Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min su You, MD; Phone Number: 82-2-2072-2228; Email: bass105@hanmail.net
• Study Contact Backup: Name: Woo Hyun Paik, MD, PhD; Phone Number: 82-2-2072-2228; Email: whpaik@snuh.org

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Min su You, MD; Phone Number: 82-2-2072-2228; Email: bass105@hanmail.net
    • Contact: Woo Hyun Paik, MD, PhD; Phone Number: 82-2-2072-2228; Email: whpaik@snuh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FCSEMS; 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; 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.; Other Names: Plastic stent; FCSEMS
Active Comparator: Plastic stent; 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; 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.; Other Names: Plastic stent; FCSEMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Taewoong Medical Co., Ltd.
• Investigators: Principal Investigator: Seoul National University Hospital Seoul National University Hospital, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1812-098-996

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No