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

NCT ID: NCT01047332

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2009-11-30

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.

Conditions

Inoperable Tumors of the Bile Duct

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Uncovered Wallstent

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

Group Type: ACTIVE_COMPARATOR

Uncovered Wallstent

Intervention Type: DEVICE

Uncovered wallstent

Partially Covered Wallstent

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

Group Type: EXPERIMENTAL

Partially Covered Wallstent

Intervention Type: DEVICE

Partially covered wallstent

Interventions

Partially Covered Wallstent

Partially covered wallstent

Intervention Type: DEVICE

Uncovered Wallstent

Uncovered wallstent

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David L. Carr-Locke, MD, FRCP

Dr. David Carr-Locke, MD, FRCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David L Carr-Locke, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

References

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.

Reference Type: RESULT

PMID: 21034891 (View on PubMed)

Other Identifiers

BS-816

Identifier Type: -

Identifier Source: org_study_id