Title
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
Near Infrared Fluorescence Cholangiography During Cholecystectomy
Phase
N/ALead Sponsor
Ohio State UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
CholecystitisIntervention/Treatment
indocyanine green ...Study Participants
99The 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.
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.
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.
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
| Event Type | Organ System | Event Term | Non-acute | Acute Cholecystitis |
|---|
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.
Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.
The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.
