Covered Vs Uncovered Metal Stents For Palliative Biliary Decompression In Inoperable Malignant Distal Bile Duct Obstruction

Study Overview

Covered vs Uncovered Metal Stents for Palliative 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.

N/A

Distal Bile Duct Obstruction

DEVICE: Covered Self-expanding metal biliary stents (C-SEMS)
DEVICE: Uncovered Self-expanding metal biliary stents (U-SEMS)

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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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-05-29	Results First Submitted 2021-11-30	Last Update Submitted that met QC Criteria 2022-03-04
First Submitted that Met QC Criteria 2013-07-18	Results First Submitted that Met QC Criteria 2022-03-04	Last Update Posted (ACTUAL) 2022-03-31
First Posted (ACTUAL) 2013-07-23	Results First Posted 2022-03-31	Last Verified 2022-03

Study Plan

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

Design Details

Primary Purpose:
Other

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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.

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.

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Patrick Yachimski, MD, MPH, Vanderbilt University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record