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

Primary Purpose

Distal Bile Duct Obstruction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Covered Self-expanding metal biliary stents (C-SEMS)
Uncovered Self-expanding metal biliary stents (U-SEMS)
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Distal Bile Duct Obstruction focused on measuring pancreatic cancer, cholangiocarcinoma, metastatic malignancy, jaundice

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

U-SEMS group

C-SEMS Group

Arm Description

Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).

Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 29, 2013
Last Updated
March 4, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01905384
Brief Title
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Official Title
Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Bile Duct Obstruction
Keywords
pancreatic cancer, cholangiocarcinoma, metastatic malignancy, jaundice

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
U-SEMS group
Arm Type
Active Comparator
Arm Description
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Arm Title
C-SEMS Group
Arm Type
Active Comparator
Arm Description
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Intervention Type
Device
Intervention Name(s)
Covered Self-expanding metal biliary stents (C-SEMS)
Intervention Description
Used for palliation of inoperable malignant distal bile duct obstruction.
Intervention Type
Device
Intervention Name(s)
Uncovered Self-expanding metal biliary stents (U-SEMS)
Intervention Description
Used for palliation of inoperable malignant distal bile duct obstructions.
Primary Outcome Measure Information:
Title
Rate of Long-term Stent Failure
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Rates of Adverse Stent-related or Intervention-related Outcomes
Description
Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Yachimski, MD, MPH
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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