- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905384
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
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
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New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
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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).
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Used for palliation of inoperable malignant distal bile duct obstructions.
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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)
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Used for palliation of inoperable malignant distal bile duct obstruction.
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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.
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One year
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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.
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One Year
|
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
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
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.
Clinical Trials on Distal Bile Duct Obstruction
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Istituto Clinico HumanitasRecruitingMalignant Bile Duct ObstructionItaly
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Theresienkrankenhaus und St. Hedwig-Klinik GmbHCompletedBile Duct Obstruction, ExtrahepaticGermany
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Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity Hospital HeidelbergRecruitingBile Duct Obstruction, ExtrahepaticGermany
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Gangnam Severance HospitalRecruitingBile Duct Obstruction, ExtrahepaticKorea, Republic of
-
Hospital del Río HortegaHospital Universitario Ramon y Cajal; Hospital General Universitario de AlicanteRecruitingCholedocholithiasis | Bile Duct; Obstruction, With CalculusSpain
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Beaujon HospitalUnknown
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Istituto Clinico HumanitasRecruiting
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Inje UniversityCompletedNeoplasms | Bile Duct Obstruction | Disorder of Bile Duct StentKorea, Republic of
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Asan Medical CenterCompletedBile Duct ObstructionKorea, Republic of
-
Gangnam Severance HospitalKorea Institute of Science and TechnologyCompletedBile Duct Obstruction, ExtrahepaticKorea, Republic of
Clinical Trials on Uncovered Self-expanding metal biliary stents (U-SEMS)
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University of Cape TownUnknownRandomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant JaundiceBiliary ObstructionSouth Africa
-
Helsinki University Central HospitalActive, not recruitingChronic Pancreatitis | Biliary StrictureFinland
-
Ajou University School of MedicineCompletedMalignant Distal Biliary StrictureKorea, Republic of
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingPerihilar CholangiocarcinomaNetherlands
-
University Hospital of CologneUniversitätsklinikum Hamburg-EppendorfNot yet recruitingLeaks, AnastomoticGermany
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Mayo ClinicWithdrawn
-
University College, LondonBarts & The London NHS Trust; University Hospitals Bristol and Weston NHS Foundation... and other collaboratorsCompletedAcute Bleeding Esophageal VaricesUnited Kingdom
-
Memorial Sloan Kettering Cancer CenterCompletedPancreatic Cancer | Unresectable Biliary-pancreatic MalignanciesUnited States
-
Hospital Universitari de BellvitgeHospital Universitario Ramon y Cajal; Complejo Hospitalario de Navarra; University... and other collaboratorsNot yet recruitingBiliary Tract Neoplasms | Pancreatic Cancer Resectable | Malignant Biliary ObstructionSpain
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Hospital Universitari de BellvitgeHospital Universitario Ramon y Cajal; Complejo Hospitalario de Navarra; University... and other collaboratorsNot yet recruitingPancreatic Cancer | Biliary Tract Neoplasms | Malignant Biliary ObstructionSpain