N/A
N=7
Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Biliary Stricture
Bottom Line
View on ClinicalTrials.gov: NCT01439620 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Feasibility of Imaging the Bile Duct With the OFDI Probe — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MGH Optical Frequency Domain Imaging (OFDI) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Imaging the Bile Duct With the OFDI Probe |
7 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01439620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.