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Covered or Uncovered Bile Duct Stents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232101
First Posted: November 2, 2010
Last Update Posted: November 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Göteborg University
  Purpose

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 The plastic stents have been replaced by self expandable metallic stents.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


Condition Intervention
Bile Duct Neoplasms Device: covered or uncovered stents

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: March 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
0
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232101


Locations
Sweden
Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,
Skovde, Sweden, SE-54185
Sponsors and Collaborators
Göteborg University
Investigators
Study Director: Kjell-Arne Ung, PhD, MD Dpt Int Med, Skovde
  More Information

Responsible Party: Kjell-Arne Ung, Consultant Gastroenterologist, Göteborg University
ClinicalTrials.gov Identifier: NCT01232101     History of Changes
Other Study ID Numbers: CUMS-01
First Submitted: November 1, 2010
First Posted: November 2, 2010
Last Update Posted: November 2, 2010
Last Verified: March 2007

Keywords provided by Göteborg University:
covered, uncovered, palliative treatment, stent

Additional relevant MeSH terms:
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases