Biliary Stricture
Conditions
Keywords
Biliary Stricture, OCT, Imaging
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.
Interventions
DEVICEMGH Optical Frequency Domain Imaging (OFDI)
Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Imaging the Bile Duct With the OFDI Probe | day 1, during diagnostic procedure | The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OFDI Imaging Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.
MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | OFDI Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 11.24 |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: day 1, during diagnostic procedure
Population: Seven subjects were enrolled and imaged in this study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optical Frequency Domain Imaging (OFDI Imaging | Feasibility of Imaging the Bile Duct With the OFDI Probe | 7 Participants |