Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Completed · Not applicable

Conditions studied: Biliary Stricture

In brief

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).

Key facts

Study ID

NCT01439620

Run by

Massachusetts General Hospital

People needed

7

Starts

2009-02-01

Expected to finish

2010-07-20

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.