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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFDI imaging | Experimental | Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGH Optical Frequency Domain Imaging (OFDI) | Device | Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD PhD | Massachusetts General Hospital | Principal Investigator |
| David Forcione, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Seven subject were enrolled and completed this study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Seven subjects were enrolled and imaged in this study | Posted | Count of Participants | Participants | day 1, during diagnostic procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Tearney, MD | Massachusetts General Hospital | Optical Frequency Domain Imagi | gtearney@partners.org |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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