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Completed

NCT Number: NCT01232101

Covered or Uncovered Bile Duct Stents

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 The plastic stents have been replaced by self expandable metallic stents.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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,

Skövde, SE-54185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

covered or uncovered stents

Device

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2010
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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