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Covered or Uncovered Bile Duct Stents

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01232101
First received: November 1, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  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 The plastic stents have been replaced by self expandable metallic stents.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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kjell-Arne Ung, Consultant Gastroenterologist, Göteborg University
ClinicalTrials.gov Identifier: NCT01232101     History of Changes
Other Study ID Numbers: CUMS-01
Study First Received: November 1, 2010
Last Updated: November 1, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013