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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905384
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick Yachimski, Vanderbilt University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Distal Bile Duct Obstruction Device: Covered Self-expanding metal biliary stents (C-SEMS) Device: Uncovered Self-expanding metal biliary stents (U-SEMS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rates of adverse stent-related or intervention-related outcomes [ Time Frame: One Year ]
    Such as pancreatitis, cholangitis, cholecystitis, perforation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905384


Locations
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United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Patrick Yachimski, MD, MPH Vanderbilt University
More Information
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Responsible Party: Patrick Yachimski, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01905384    
Other Study ID Numbers: 130331
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Patrick Yachimski, Vanderbilt University Medical Center:
pancreatic cancer
cholangiocarcinoma
metastatic malignancy
jaundice
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases