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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:
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: January 31, 2017
Last verified: January 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: Wallstent
Device: Non-Covered 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:
  • To compare the stent patency time in the uncovered and covered Wallstent groups in subjects with malignant bile duct strictures. [ Time Frame: 3 years ]

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
Experimental: Covered Wallstent
Endoscopically-placed self-expanding biliary metal stent (covered type)
Device: Wallstent
Covered wallstent
Active Comparator: Non-Covered Wallstent
Endoscopically-placed self-expanding biliary metal stent (uncovered type)
Device: Non-Covered Wallstent
non-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). Inclusion criteria are (1) age ≥18 years; (2) malignant distal (≥1 cm distal to the biliary hilum) biliary obstruction amenable to stent placement; and (3) not a candidate for curative surgical resection due to tumor stage, operative risk, or patient wishes. Exclusion criteria are (1) inability to obtain informed consent, (2) contraindication to ERCP, (3) prior biliary SEMS placement, and (4) prior biliary surgery. Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or 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:

  • 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

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
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on March 27, 2017