Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

NCT ID: NCT01439620

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-07-20

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.

Conditions

Biliary Stricture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

OFDI imaging

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

Group Type: EXPERIMENTAL

MGH Optical Frequency Domain Imaging (OFDI)

Intervention Type: DEVICE

Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System

Interventions

MGH Optical Frequency Domain Imaging (OFDI)

Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Tearney

Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Tearney, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

David Forcione, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2008-P-000794

Identifier Type: -

Identifier Source: org_study_id