Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Not Applicable

Completed

• Conditions: Biliary Stricture
• Interventions: Device: MGH Optical Frequency Domain Imaging (OFDI)

• Registration Number: NCT01439620
• Lead Sponsor: Massachusetts General Hospital

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 cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).

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) 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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-07-20
• Study Completion: 2010-07-20
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Results First Submitted: 2018-07-24
• Results First Submitted QC: 2018-08-21
• Results First Posted: 2018-09-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI imaging	MGH Optical Frequency Domain Imaging (OFDI)	Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.

Primary Outcome Measures

Name	Time	Method
Feasibility of Imaging the Bile Duct With the OFDI Probe	day 1, during diagnostic procedure	The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States