A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Study Overview

• Status: Recruiting
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Device: fully covered self-expandable metal stent with an anchoring external plastic stent; Device: uncovered self-expandable metal stent

Detailed Description

This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sang Hyub Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with 19 years of age or older
• Those who voluntarily consented to the trial and signed a written consent
• Inoperable malignant biliary obstruction

Exclusion Criteria:

• Previous surgical biliary drainage
• Patients continuosly requiring percutaneous transhepatic biliary drainage
• History of biliary drainage with metal stent
• Biliary obstruction located in hilum or intrahepatic duct
• Patients with life expectancy of 3 months or less
• On pregnancy
• Unable to underwent endoscopic procedures

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: fc-SEMS with anchoring plastic stent; fully covered self-expanable metal stent with an external anchoring plastic stent	Device: fully covered self-expandable metal stent with an anchoring external plastic stent; Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
Active Comparator: uc-SEMS; uncovered self-expandable metal stent	Device: uncovered self-expandable metal stent; Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patent stent	The number of patient without stent dysfuction divided by total number of patients	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent obstruction	Suspected by jaundice (Total bilirubin > 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP	1 year
Stent migration	Radiologic finding of migration through Abdomen X-ray or CT scan	1 year
Re-intervention	Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage	1 year
Adverse event	acute cholangitis, acute cholecystitis, acute pancreatitis	1 year
Overall survival	Timespan from the diagnosis to the death	1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Anticipated): October 24, 2023
• Study Completion (Anticipated): October 24, 2024

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Fully Covered Self Expandable Metal Stent; Uncovered Self Expandable Metal Stent
• Other Study ID Numbers: H-2012-043-1179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No