Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
Overview
- Phase
- Phase 1
- Intervention
- Indocyanine Green (ICG)
- Conditions
- Acute Cholecystitis
- Sponsor
- Ohio State University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Adverse events related to use of indocyanine green (ICG)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Narula, Vimal K, MD
Associate Professor
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •Age 18-89
- •Planned laparoscopic cholecystectomy
Exclusion Criteria
- •Inability to provide informed consent
- •Allergy to ICG, iodine, and/or shellfish
- •Lactating
Arms & Interventions
NIRF-C and IOC
Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
Intervention: Indocyanine Green (ICG)
NIRF-C and IOC
Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
Intervention: Near Infrared Fluorescence Cholangiography (NIRF-C)
Outcomes
Primary Outcomes
Adverse events related to use of indocyanine green (ICG)
Time Frame: Injection to 2 wk follow-up
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.
Procedure time
Time Frame: Intraoperative
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Anatomic identification with NIRF-C and IOC
Time Frame: Intraoperative
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.