Covered or Uncovered Bile Duct Stents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-08-31

Brief Summary

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The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.

These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.

The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

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Detailed Description

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Conditions

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Bile Duct Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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covered self expandable metallic stents

Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent

Group Type ACTIVE_COMPARATOR

covered or uncovered stents

Intervention Type DEVICE

Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.

Uncovered self expandable metallic stent

Group Type ACTIVE_COMPARATOR

covered or uncovered stents

Intervention Type DEVICE

Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.

Interventions

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covered or uncovered stents

Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.

Intervention Type DEVICE

Other Intervention Names

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ERCP Bile duct neoplasms

Eligibility Criteria

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Inclusion Criteria

* Patients with unresectable, distal bile duct stricture needing relieved endoscopically
* Expected survival greater than 3 months
* The patient must give written consent to participate in the study