Clinical trial NCT01047332: A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Official title: A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inoperable Tumors of the Bile Duct
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2010-01-12
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Time to Recurrent Biliary Obstruction
timeFrame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Secondary outcomes:
measure: Patient Survival
timeFrame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From time of stent placement to participant death or lost to follow-up (up to 1302 days)
measure: Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism
timeFrame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: David L Carr-Locke, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.