Clinical trial NCT01439620: Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Official title: Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Stricture
Keywords: Biliary Stricture
OCT
Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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 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

Primary outcomes:
measure: Feasibility of Imaging the Bile Duct With the OFDI Probe
timeFrame: day 1, during diagnostic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: David Forcione, MD
role: PRINCIPAL_INVESTIGATOR
References: