A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
This trial is active, not recruiting.
|Condition||inoperable tumors of the bile duct|
|Treatments||wallstent, non-covered wallstent|
|Sponsor||Brigham and Women's Hospital|
|Collaborator||Boston Scientific Corporation|
|Start date||August 2002|
|End date||November 2009|
|Trial size||276 participants|
|Trial identifier||NCT01047332, BS-816|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
|Primary purpose||supportive care|
To compare the stent patency time in the uncovered and covered Wallstent groups in subjects with malignant bile duct strictures.
time frame: 3 years
Male or female participants at least 18 years old.
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.
|Official title||A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures|
|Principal investigator||David L Carr-Locke, MD, FRCP|
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