Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order
to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent
placement subjects will undergo the placement of a radiofrequency ablation catheter into the
bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and
prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent
will be placed. Three days after the procedure subjects will receive a phone call from the
research coordinator to check any adverse or unwanted effects of the treatment. The study
procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects
will undergo routine follow up for their medical problems. No follow up visits are required
as part of the study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety: Number of bile leak after RFA procedure
Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)
2 years
Yes
William R Brugge, M.D.
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
11-405
NCT01543607
February 2012
June 2014
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |