Covered or Uncovered Bile Duct Stents

November 1, 2010 updated by: Göteborg University

Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.

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 The plastic stents have been replaced by self expandable metallic stents.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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

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

  • Sweden
      • Skovde, Sweden, SE-54185
        • Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Stricture close to hilus
  • Need for interpreter

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: covered self expandable metallic stents
Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent
Device: 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.
Other Names:
  • ERCP
  • Bile duct neoplasms
ACTIVE_COMPARATOR: Uncovered self expandable metallic stent
Device: 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.
Other Names:
  • ERCP
  • Bile duct neoplasms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS
Time Frame: Stent occlusion or patient death
Stent occlusion or patient death

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents
Time Frame: Evaluated within three days
Evaluated within three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Study Director: Kjell-Arne Ung, PhD, MD, Dpt Int Med, Skovde

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

March 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUMS-01

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.

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