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

NCT01905384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-31

Study results available
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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.

Conditions

  • Distal Bile Duct Obstruction

Interventions

DEVICE

Covered Self-expanding metal biliary stents (C-SEMS)

Used for palliation of inoperable malignant distal bile duct obstruction.

DEVICE

Uncovered Self-expanding metal biliary stents (U-SEMS)

Used for palliation of inoperable malignant distal bile duct obstructions.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Patrick Yachimski, MD, MPH · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905384 on ClinicalTrials.gov