Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
Near Infrared Fluorescence Cholangiography During Cholecystectomy
  • Phase

  • Study Type

  • Intervention/Treatment

    indocyanine green ...
  • Study Participants

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.
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.
Study Started
Jan 31
Primary Completion
Aug 31
Study Completion
Aug 31
Results Posted
Oct 21
Last Update
Oct 21

Drug Injection of indocyanine green (ICG)

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.

Device Near Infrared Cholangiography Fluorescence (NIRF-C)

These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.

  • Other names: Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)

NIRF-C Experimental

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
Allergy to ICG, iodine, and/or shellfish
Acute cholecystitis, cholangitis, and/or cirrhosis (main study)



Acute Cholecystitis

All Events

Event Type Organ System Event Term Non-acute Acute Cholecystitis

Complications Related to ICG

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.


Acute Cholecystitis

Incidence of Anatomic Identification With NIRF-C

Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.


percentage of biliary anatomy observatio

Acute Cholecystitis

percentage of biliary anatomy observatio

Time to Complete NIRF-C and IOC

The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.


minutes (Mean)
Full Range: 0.2 to 3.6

Acute Cholecystitis

minutes (Mean)
Full Range: 0.25 to 1.28



Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study


Acute Cholecystitis