Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

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

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).

Study Overview

• Status: Completed
• Conditions: Biliary Stricture
• Intervention / Treatment: Device: MGH Optical Frequency Domain Imaging (OFDI)

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OFDI imaging; 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); Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Guillermo Tearney, MD PhD, Massachusetts General Hospital; Principal Investigator: David Forcione, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): July 20, 2009
• Study Completion (Actual): July 20, 2010

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: OCT; Imaging; Biliary Stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: 2008-P-000794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No