Near Infrared Fluorescence Cholangiography During Cholecystectomy
Overview
- Phase
- Not Applicable
- Intervention
- Injection of indocyanine green (ICG)
- Conditions
- Cholecystitis
- Sponsor
- Ohio State University
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Complications Related to ICG
- Status
- Completed
- Last Updated
- 10 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). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.
Detailed Description
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.
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
- •Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
- •Lactating
Arms & Interventions
NIRF-C
Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.
Intervention: Injection of indocyanine green (ICG)
NIRF-C
Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.
Intervention: Near Infrared Cholangiography Fluorescence (NIRF-C)
Outcomes
Primary Outcomes
Complications Related to ICG
Time Frame: From time of injection to 1st post-op follow-up
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.
Secondary Outcomes
- Incidence of Anatomic Identification With NIRF-C(Intraoperative)
- Time to Complete NIRF-C and IOC(Intraoperative)