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) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.
Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Adverse events related to use of indocyanine green (ICG)
Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.
Time frame: Injection to 2 wk follow-up
Anatomic identification with NIRF-C and IOC
Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.
Time frame: Intraoperative
Procedure time
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Time frame: Intraoperative
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