Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439620
• Other study ID #: 2008-P-000794
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: July 20, 2010

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 20, 2010
• Est. primary completion date: July 20, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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