Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01439620
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):
Guillermo Tearney, 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).

Condition or disease Intervention/treatment Phase
Biliary Stricture Device: MGH Optical Frequency Domain Imaging (OFDI) Phase 1

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OFDI imaging
Subject will swallow an OFDI capsule and images will be acquires using 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

Primary Outcome Measures :
  1. Sensitivity and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes ]
    Images will be analyzed to assess common bile duct and common hepatic duct strictures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01439620

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
Principal Investigator: David Forcione, MD Massachusetts General Hospital

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital Identifier: NCT01439620     History of Changes
Other Study ID Numbers: 2008-P-000794
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Biliary Stricture

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases