Status:
COMPLETED
Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Biliary Stricture
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining chola...
Detailed Description
The study will be conducted in approximately 20 patients with known or suspected common bile duct or common hepatic duct stricture scheduled for endoscopic retrograde cholangiopancreatography (ERCP) w...
Eligibility Criteria
Inclusion
- Patient age ≥18 and up to 75 years old
- Patients able to give informed consent
- Patients with bile duct measuring ≥4 mm in diameter
- Patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ERCP for indications other than participation in the study
- Women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure
Exclusion
- Patients with pancreatitis
- Pregnant women
- Patients on oral anticoagulant (warfarin) therapy
- Patients with known history of hemostatic disorder
- Patients found to have a biliary fistula on diagnostic ERCP
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01439620
Start Date
February 1 2009
End Date
July 20 2010
Last Update
April 10 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114