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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047332
First Posted: January 12, 2010
Last Update Posted: April 11, 2017
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.
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital
  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: Double (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 David L. Carr-Locke, MD, FRCP, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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): 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
First Submitted: January 8, 2010
First Posted: January 12, 2010
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No