Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Cholecystitis

Acalculous Cholecystitis

Gastrointestinal Diseases

Gallbladder Diseases

Biliary Tract Diseases

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.

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).

Indocyanine green

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.

PINPOINT Endoscopic Fluorescence

Ali Zarrinpar, MD, PhD

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.

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.

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.

To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.

Low Dose ICG for Biliary Tract and Tumor Imaging

Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors

We are not sharing individual participant data with other researchers

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver

A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat

Society of University Surgeons

University of Florida

ICG is a very safe drug with minimal risk for adverse advents. Participants were given a very low dose

Study participants who received low dose ICG.

Low Dose

Study participants who received standard dose ICG.

Standard Dose

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Indocyanine green: 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).

Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.

Indocyanine green: 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).

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

White

Black

Asian

Race/Ethnicity, Customized

United States

Region of Enrollment

5 enrolled and randomized patients were excluded from analysis because their videos were either too dark or unusable due to technical issues with the scope, camera, or device tower.

Dr. Ali Zarrinpar

Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light

Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.

Indocyanine green: 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)

Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio

Common Hepatic Duct

Cystic Duct

Common Bile Duct

Aberrant Duct

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Indocyanine green: 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).

PINPOINT Endoscopic Fluorescence: 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.

Spots Global Cancer Trial Database for pinpoint endoscopic fluorescence