Low Dose ICG for Biliary Tract and Tumor Imaging
Condition: Cholecystitis; Hepatocellular Carcinoma; Liver Metastases
MeSH terms: Cholecystitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green
      (ICG) allows for the intraoperative identification of liver anatomy. The investigators have
      new data that a much lower dose improves this visualization. Confirmation of this hypothesis
      would mean that ICG can be administered on the same day of surgery in order to augment
      real-time intraoperative visualization, thereby providing a safe, feasible, and
      cost-effective strategy for the surgical treatment of liver disease.
    

Detailed description: 
      The investigators have a series of surgical cases in which the investigators have been able
      to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200
      fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose
      was visible in about 15-20 minutes from the time of injection with low liver background
      fluorescence, a significant improvement that would make its utilization in the operating room
      more practical. The investigators hypothesize that a lower dose will: 1) allow adequate
      visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and
      common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be
      administered on the same day of surgery in order to augment real-time intraoperative
      localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and
      cost-effective strategy for the surgical treatment of liver disease.

      The investigators intend to test our hypothesis with the following specific aims:

      Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a
      previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.
    

Intervention name(s): Indocyanine green; PINPOINT Endoscopic Fluorescence
Intervention type(s): Drug; Device
Intervention description(s): Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).; The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.
Other intervention name(s): ICG; NIRF
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Biliary Tract; Indocyanine Green (ICG); Tumors; Near-infrared Fluorescence