A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01047332
First received: January 8, 2010
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.


Condition Intervention
Inoperable Tumors of the Bile Duct
Device: Wallstent
Device: Non-Covered Wallstent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • To compare the stent patency time in the uncovered and covered Wallstent groups in subjects with malignant bile duct strictures. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 276
Study Start Date: August 2002
Estimated Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Covered Wallstent Device: Wallstent
Covered wallstent
Active Comparator: Non-Covered Wallstent Device: Non-Covered Wallstent
non-covered wallstent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • greater than 18 years of age.
  • Malignant bile duct stricture.
  • Increased bilirubin.
  • Duct stricture is > 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
  • Not an operative candidate.

Exclusion Criteria:

  • Unable to obtain consent.
  • Unable to tolerate procedure.
  • Suspected benign bile duct stricture.
  • Candidate for potentially curative surgical intervention.
  • Previous metallic biliary stent.
  • Previous bile duct surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047332

Sponsors and Collaborators
Brigham and Women's Hospital
Boston Scientific Corporation
Investigators
Principal Investigator: David L Carr-Locke, MD, FRCP Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. David Carr-Locke, MD, FRCP, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01047332     History of Changes
Other Study ID Numbers: BS-816
Study First Received: January 8, 2010
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014