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

Inoperable Tumors of the Bile Duct Clinical Trial

— Wallstent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047332
• Other study ID #: BS-816
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: January 31, 2017
• Start date: October 2002
• Est. completion date: November 2009

Study information

• Verified date: January 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Inoperable Tumors of the Bile Duct

Intervention

Device:
• Wallstent
Covered wallstent
• Non-Covered Wallstent
non-covered wallstent

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston Scientific Corporation

References & Publications (1)

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-exp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the stent patency time in the uncovered and covered Wallstent groups in subjects with malignant bile duct strictures.		3 years