Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | August 2014 |
Near Infrared Fluorescence Cholangiography During Cholecystectomy
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to
assist in real-time identification of anatomy during cholecystectomy (gallbladder removal).
We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction
during cholecystectomy.
assist in real-time identification of anatomy during cholecystectomy (gallbladder removal).
We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction
during cholecystectomy.
This study is designed to determine the clinical utility of intravenous indocyanine green
(ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the
biliary tree with a near-infrared light source and camera. Testing will be done during an
abdominal surgery which requires gallbladder removal. Subjects will be recruited during
consult for their surgical procedure. The study itself will take an estimated 5 minutes
during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before
surgery, and following perfusion of the biliary tree, images will be recorded and visibility
of the appropriate anatomy will be assessed using a near-infrared light source and camera.
If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may
be given. Following the completion of imaging, the standard procedure for cholecystectomy
will be performed including intraoperative cholangiography (IOC), which is standard of care.
Subject post-operative recovery will be monitored for the duration of their hospital stay.
Adverse events will be monitored at the patient's routine follow up visit.
(ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the
biliary tree with a near-infrared light source and camera. Testing will be done during an
abdominal surgery which requires gallbladder removal. Subjects will be recruited during
consult for their surgical procedure. The study itself will take an estimated 5 minutes
during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before
surgery, and following perfusion of the biliary tree, images will be recorded and visibility
of the appropriate anatomy will be assessed using a near-infrared light source and camera.
If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may
be given. Following the completion of imaging, the standard procedure for cholecystectomy
will be performed including intraoperative cholangiography (IOC), which is standard of care.
Subject post-operative recovery will be monitored for the duration of their hospital stay.
Adverse events will be monitored at the patient's routine follow up visit.
Inclusion Criteria:
- Age 18-89
- Planned laparoscopic cholecystectomy
Exclusion Criteria:
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
- Lactating
We found this trial at
1
site
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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