Indocyanine green (ICG) fluorescent cholangiography during laparoscopic cholecystectomy using RUBINA™ technology: preliminary experience in two pediatric surgery centers

Background Recently, we reported the feasibility of indocyanine green (ICG) near-infrared fluorescence (NIRF) imaging to identify extrahepatic biliary anatomy during laparoscopic cholecystectomy (LC) in pediatric patients. This paper aimed to describe the use of a new technology, RUBINA™, to perform intra-operative ICG fluorescent cholangiography (FC) in pediatric LC. Methods During the last year, ICG-FC was performed during LC using the new technology RUBINA™ in two pediatric surgery units. The ICG dosage was 0.35 mg/Kg and the median timing of administration was 15.6 h prior to surgery. Patient baseline, intra-operative details, rate of biliary anatomy identification, utilization ease, and surgical outcomes were assessed. Results Thirteen patients (11 girls), with median age at surgery of 12.9 years, underwent LC using the new RUBINA™ technology. Six patients (46.1%) had associated comorbidities and five (38.5%) were practicing drug therapy. Pre-operative workup included ultrasound (n = 13) and cholangio-MRI (n = 5), excluding biliary and/or vascular anatomical anomalies. One patient needed conversion to open surgery and was excluded from the study. The median operative time was 96.9 min (range 55–180). Technical failure of intra-operative ICG-NIRF visualization occurred in 2/12 patients (16.7%). In the other cases, ICG-NIRF allowed to identify biliary/vascular anatomic anomalies in 4/12 (33.3%), including Moynihan's hump of the right hepatic artery (n = 1), supravescicular bile duct (n = 1), and short cystic duct (n = 2). No allergic or adverse reactions to ICG, post-operative complications, or reoperations were reported. Conclusion Our preliminary experience suggested that the new RUBINA™ technology was very effective to perform ICG-FC during LC in pediatric patients. The advantages of this technology include the possibility to overlay the ICG-NIRF data onto the standard white light image and provide surgeons a constant fluorescence imaging of the target anatomy to assess position of critical biliary structures or presence of anatomical anomalies and safely perform the operation.

P11: NEAR INFRARED FLUORESCENT CHOLANGIOGRAPHY IN LAPAROSCOPIC CHOLECYSTECTOMY: A SINGLE CENTRE FEASIBILITY STUDY. THE OPTIMUM DOSING REGIME, LIMITATIONS AND WHERE NEXT?

Introduction This study explored near-infrared fluorescent cholangiography (NIRFC) with Indocyanine Green (ICG) during laparoscopic cholecystectomy (LC) surgery in a tertiary referral hepatobiliary unit. ICG binds to albumin and is excreted in bile. NIRFC utilises the fluorescent and excretory properties of ICG to provide dynamic extrahepatic bile duct mapping during LC. Method Non-randomised single centre feasibility study. Twenty-two participants were sequentially allocated to four dosing subgroups prior to NIRFC assisted LC. Each received a single intravenous dose of ICG prior to LC with the Stryker Novadaq NIR laparoscope. The biliary anatomy was assessed with NIRFC at three time-points, detection was compared to radiological cholangiogram where available and surgeon satisfaction was assessed. Result Eight participants received 2.5mg ICG 20-40min before surgery, four 0.25mg/kg 20-40min, five 90min – 180min and five 12 – 36 hour pre-operatively. Average age 50 years (S.D±15), BMI 27.5m2 (S.D±3.6), 6/22 were acute LC procedures. The prolonged dosing interval produced increased extrahepatic biliary structure identification (p = 0.016), reduced noise to signal ratio and was consistently preferred by the operating surgeon. NIRFC was inferior to radiological cholangiogram (n = 10) (p = 0.014) for bile duct mapping. We observed iatrogenic bile spillage saturating the field and obscuring structure differentiation and peri-hilar inflammation impeding fluorescent detection in acute LC. Conclusion The dosing regimen 0.25mg/kg ICG 12 to 36 hours prior to surgery provides optimum NIRFC structure visualisation. Fluorescent tissue penetrance is limited in acute peri-hilar inflammation. More research in to the efficiency of NIRFC in emergency LC is required. Take-home message An intravenous dose of 0.25mg/kg of Indocyanine Green 12 to 36 hours before surgery is the optimum dosing regimen for increased extra-hepatic bile duct structures with near infrared fluorescent cholangiography. The role of NIRFC in acute laparoscopic cholecystectomy surgery remains ill-defined.