Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
- Conditions
- Cholecystitis
- Interventions
- Drug: Injection of indocyanine green (ICG)Device: Near Infrared Cholangiography Fluorescence (NIRF-C)
- Registration Number
- NCT02070640
- Lead Sponsor
- Ohio State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- Age 18-89
- Planned laparoscopic cholecystectomy
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
- Lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NIRF-C Injection of indocyanine green (ICG) 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. NIRF-C Near Infrared Cholangiography Fluorescence (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.
- Primary Outcome Measures
Name Time Method Complications Related to ICG 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 Outcome Measures
Name Time Method Incidence of Anatomic Identification With NIRF-C Intraoperative Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.
Time to Complete NIRF-C and IOC Intraoperative The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.
Trial Locations
- Locations (1)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States