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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
99
2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Complications Related to ICG
A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.
Time frame: From time of injection to 1st post-op follow-up
Incidence of Anatomic Identification With NIRF-C
Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.
Time frame: Intraoperative
Time to Complete NIRF-C and IOC
The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.
Time frame: Intraoperative
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