Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01047332
First received: January 8, 2010
Last updated: February 28, 2017
Last verified: February 2017
  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: Partially Covered Wallstent
Device: Uncovered Wallstent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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

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

Primary Outcome Measures:
  • Time to Recurrent Biliary Obstruction [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]
    Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.


Secondary Outcome Measures:
  • Patient Survival [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]
    Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From time of stent placement to participant death or lost to follow-up (up to 1302 days) ]
    Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.

  • Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]
    Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.


Enrollment: 129
Actual Study Start Date: October 2002
Study Completion Date: November 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Uncovered Wallstent
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Device: Uncovered Wallstent
Uncovered wallstent
Experimental: Partially Covered Wallstent
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Device: Partially Covered Wallstent
Partially covered wallstent

Detailed Description:

This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).

Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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

Publications:
Responsible Party: David L. Carr-Locke, MD, FRCP, 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
Results First Received: February 28, 2017
Last Updated: February 28, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on April 28, 2017