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Introduction: Near-infrared fluorescence cholangiography (NIRF-C) is a popular application of fluorescence image-guided surgery (FIGS). NIRF-C requires near-infrared optimized laparoscopes and the injection of a fluorophore, most frequently Indocyanine Green (ICG), to highlight the biliary anatomy. It is investigated as a tool to increase safety during cholecystectomy. The European registry on FIGS (EURO-FIGS: www.euro-figs.eu ) aims to obtain a snapshot of the current practices of FIGS across Europe. Data on NIRF-C are presented., Methods: EURO-FIGS is a secured online database which collects anonymized data on surgical procedures performed using FIGS. Data collected for NIRF-C include gender, age, Body Mass Index (BMI), pathology, NIR device, ICG dose, ICG timing of administration before intraoperative visualization, visualization (Y/N) of biliary structures such as the cystic duct (CD), the common bile duct (CBD), the CD-CBD junction, the common hepatic duct (CHD), Visualization scores, adverse reactions to ICG, operative time, and surgical complications., Results: Fifteen surgeons (12 European surgical centers) uploaded 314 cases of NIRF-C during cholecystectomy (cholelithiasis n = 249, cholecystitis n = 58, polyps n = 7), using 4 different NIR devices. ICG doses (mg/kg) varied largely (mean 0.28 ± 0.17, median 0.3, range: 0.02-0.62). Similarly, injection-to-visualization timing (minutes) varied largely (mean 217 ± 357; median 57), ranging from 1 min (direct intragallbladder injection in 2 cases) to 3120 min (n = 2 cases). Visualization scores before dissection were significantly correlated, at univariate analysis, with ICG timing (all structures), ICG dose (CD-CBD), device (CD and CD-CBD), surgeon (CD and CD-CBD), and pathology (CD and CD-CBD). BMI was not correlated. At multivariate analysis, pathology and timing remained significant factors affecting the visualization scores of all three structures, whereas ICG dose remained correlated with HD visualization only., Conclusions: The EURO-FIGS registry has confirmed a wide disparity in ICG dose and timing in NIRF-C. EURO-FIGS can represent a valuable tool to promote and monitor FIGS-related educational and consensus activities in Europe.

Background: Though often only briefly described in the literature, there are clearly factors that have an influence on the fluorescence intensity, and thereby the usefulness of the technique. This article aims to provide an overview of the factors influencing the fluorescence intensity of fluorescence imaging with Indocyanine green, primarily focussed on NIRF guided cholangiography., Methods: A systematic search was conducted to gain an overview of currently used methods in NIRF imaging in laparoscopic cholecystectomies. Relevant literature was searched to gain advice on what methods to use. Ex vivo experiments were performed to assess various factors that influence fluorescence intensity and whether the found clinical advices can be confirmed., Results: ICG is currently the most widely applied fluorescent dye. Optimal ICG concentration lies between 0.00195 and 0.025 mg/ml, and this dose should be given as early as achievable-but maximum 24 h-before surgery. When holding the laparoscope closer and perpendicular to the dye, the signal is most intense. In patients with a higher BMI and/or cholecystitis, fluorescence intensity is lower, but NIRF seems to be more helpful. There are differences between various marketed fluorescence systems. Also, no uniform method to assess fluorescence intensity is available yet., Conclusions: This study identified and discussed several factors that influence the signal of fluorescence cholangiography. These factors should be taken into account when using NIRF cholangiography. Also, surgeons should be aware of new dyes and clinical systems, in order to benefit most from the potential of NIRF imaging.

Introduction: Misidentification of the extrahepatic bile duct anatomy during laparoscopic cholecystectomy (LC) is the main cause of bile duct injury. Easier intraoperative recognition of the biliary anatomy may be accomplished by using near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG). Promising results were reported for successful intraoperative identification of the extrahepatic bile ducts compared to conventional laparoscopic imaging. However, routine use of ICG fluorescence laparoscopy has not gained wide clinical acceptance yet due to a lack of high-quality clinical data. Therefore, this multicentre randomised clinical study was designed to assess the potential added value of the NIRF imaging technique during LC., Methods and Analysis: A multicentre, randomised controlled clinical trial will be carried out to assess the use of NIRF imaging in LC. In total, 308 patients scheduled for an elective LC will be included. These patients will be randomised into a NIRF imaging laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. The primary end point is time to 'critical view of safety' (CVS). Secondary end points are 'time to identification of the cystic duct (CD), of the common bile duct, the transition of CD in the gallbladder and the transition of the cystic artery in the gallbladder, these all during dissection of CVS'; 'total surgical time'; 'intraoperative bile leakage from the gallbladder or cystic duct'; 'bile duct injury'; 'postoperative length of stay', 'complications due to the injected ICG'; 'conversion to open cholecystectomy'; 'postoperative complications (until 90 days postoperatively)' and 'cost-minimisation'., Ethics and Dissemination: The protocol has been approved by the Medical Ethical Committee of Maastricht University Medical Center/Maastricht University; the trial has been registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations., Trial Registration Number: NCT02558556., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Aim: To assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy. Methods: This international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to 'Critical View of Safety' (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points. Results: A total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG. Conclusion: Use of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder. [ABSTRACT FROM AUTHOR]