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Paclitaxel Eluting Covered Metallic Stent for Unresectable Malignant Bile Duct Obstruction

NCT00453076 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2010-06-11

No results posted yet for this study

Summary

The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unresectable malignant bile duct stricture.

The secondary goals are to assess reinterventions, complications, technical difficulties, and physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self expandable metallic stent.

Conditions

  • Bile Duct Obstruction

Interventions

DEVICE

Paclitaxel eluting covered metal stent and control covered metal stent

Paclitaxel eluting covered metal stent and control covered metal stent are inserted with standard ERCP technique

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Myung-Hwan Kim, MD,PhD · Asan 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
2006-11-30
Primary Completion
2008-06-30
Completion
2009-06-30

Countries

  • South Korea

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 NCT00453076 on ClinicalTrials.gov