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Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

NCT01038713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-06-23

Study results available
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Summary

This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.

Conditions

Interventions

DEVICE

Biliary stent placement

Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Timothy Gardner, M.D. · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01038713 on ClinicalTrials.gov