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Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01439620
First received: September 20, 2011
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Biliary Stricture
 Device: MGH Optical Frequency Domain Imaging (OFDI) System
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Images will be analyzed to assess common bile duct and common hepatic duct strictures


Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFDI imaging
OFDI imaging
 Device: MGH Optical Frequency Domain Imaging (OFDI) System
Imaging of biliary tract with OFDI system

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439620

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

No publications provided

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01439620     History of Changes
Other Study ID Numbers: 2008-P-000794
Study First Received: September 20, 2011
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Biliary Stricture
OCT
Imaging

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

ClinicalTrials.gov processed this record on June 17, 2013