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

Primary Purpose

Inoperable Tumors of the Bile Duct

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Partially Covered Wallstent
Uncovered Wallstent
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inoperable Tumors of the Bile Duct

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Uncovered Wallstent

    Partially Covered Wallstent

    Arm Description

    Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).

    Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).

    Outcomes

    Primary Outcome Measures

    Time to Recurrent Biliary Obstruction
    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
    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)
    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
    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.

    Full Information

    First Posted
    January 8, 2010
    Last Updated
    February 28, 2017
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01047332
    Brief Title
    A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
    Acronym
    Wallstent
    Official Title
    A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (Actual)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    Boston Scientific Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inoperable Tumors of the Bile Duct

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    129 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Uncovered Wallstent
    Arm Type
    Active Comparator
    Arm Description
    Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
    Arm Title
    Partially Covered Wallstent
    Arm Type
    Experimental
    Arm Description
    Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
    Intervention Type
    Device
    Intervention Name(s)
    Partially Covered Wallstent
    Intervention Description
    Partially covered wallstent
    Intervention Type
    Device
    Intervention Name(s)
    Uncovered Wallstent
    Intervention Description
    Uncovered wallstent
    Primary Outcome Measure Information:
    Title
    Time to Recurrent Biliary Obstruction
    Description
    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.
    Time Frame
    Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
    Secondary Outcome Measure Information:
    Title
    Patient Survival
    Description
    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.
    Time Frame
    Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
    Title
    Number of Participants With Serious Adverse Events (SAEs)
    Description
    Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.
    Time Frame
    From time of stent placement to participant death or lost to follow-up (up to 1302 days)
    Title
    Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism
    Description
    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.
    Time Frame
    Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David L Carr-Locke, MD, FRCP
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21034891
    Citation
    Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021.
    Results Reference
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    A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

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