Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

March 4, 2022 updated by: Patrick Yachimski, Vanderbilt University Medical Center

Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
  • 18 years of age or older
  • serum bilirubin > 2mg/dL

Exclusion Criteria:

  • prior endoscopic or percutaneous biliary drainage
  • post-surgical anatomy
  • primary site of biliary obstruction involving the common hepatic duct or hilum
  • tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: U-SEMS group
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Device: Uncovered Self-expanding metal biliary stents (U-SEMS)
Used for palliation of inoperable malignant distal bile duct obstructions.
Active Comparator: C-SEMS Group
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Device: Covered Self-expanding metal biliary stents (C-SEMS)
Used for palliation of inoperable malignant distal bile duct obstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Long-term Stent Failure
Time Frame: One year
Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Adverse Stent-related or Intervention-related Outcomes
Time Frame: One Year
Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Patrick Yachimski, MD, MPH, Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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