Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Mass General Brigham

Status: Completed

Conditions: Biliary Stricture

Treatments: Device: MGH Optical Frequency Domain Imaging (OFDI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01439620

2008-P-000794

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

OFDI imaging

Experimental group

Description:

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

Treatment:

Device: MGH Optical Frequency Domain Imaging (OFDI)