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Clinical Trials/NCT01232101
NCT01232101CompletedNot Applicable

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

Göteborg University2 sites in 1 country71 target enrollmentStarted: March 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
71
Locations
2
Primary Endpoint
The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS

Study Overview

Brief Summary

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 The plastic stents have been replaced by self expandable metallic stents.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

Detailed Description

0

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents(Evaluated within three days)

Investigators

Sponsor
Göteborg University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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