Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Study Overview
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Brief Summary
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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 cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).

Detailed Description
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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) with duodenoscope-assisted cholangiopancreatoscopy (DACP) and biopsy. Following initial fluoroscopic evaluation, the study experimental procedure will begin. The catheter will be passed through the auxiliary channel of the duodenoscope, across the papilla and into the common bile duct. The extra-biliary portion of the catheter will be visible by the duodenoscope at all times. The intrabiliary portion of the catheter will be visible by fluoroscopy, and will be positioned across the biliary stricture. Rotational cross-sectional images of the bile duct will be obtained using the OFDI imaging catheter while pulling back the internal optical components over a pre-determined length. OFDI imaging will be conducted approximately from 1 cm distal to 1 cm and proximal to the stricture margins identified by fluoroscopy.

Official Title
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Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Conditions
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Biliary Stricture

Intervention / Treatment
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* Device: MGH Optical Frequency Domain Imaging (OFDI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI imaging<br>Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system. | Device: MGH Optical Frequency Domain Imaging (OFDI)<br>* Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Imaging the Bile Duct With the OFDI Probe | The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures. | day 1, during diagnostic procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary Stricture, OCT, Imaging