Chapter 4 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3211, registration number NTR3211 (NIRFC‐LC study). Consecutive male and female patients, aged 18 years and above, scheduled for elective laparoscopic cholecystectomy and with written informed consent, were eligible for inclusion in this study. Indications for surgery were: cholecystolithiasis, cholecystitis, cholecystectomy after biliary pancreatitis. Patients were excluded in case of liver or renal insufficiency, known iodine or ICG hypersensitivity and pregnancy (all are contraindications for the use of intravenous ICG). Laparoscopic fluorescence imaging system A novel, commercially available laparoscopic fluorescence imaging system (Karl Storz GmbH & CO. KG, Tuttlingen, Germany) ‐including a plasma light guide and 30‐degree 10‐mm laparoscope applicable for white light, autofluorescence and ICG imaging‐ was used for intraoperative conventional imaging (WL‐mode) and near‐infrared fluorescence imaging (ICG‐mode). The system is equipped with a foot pedal, allowing the surgeon to easily switch from WL‐mode to ICG‐mode, and back. Because of the instantaneous changing of images and the stable position of the laparoscope, anatomical orientation can be maintained. However, direct fluorescence image‐overlay on the conventional anatomical image is not yet possible with this system. ICG administration In all patients 2.5mg of ICG (Infracyanine®; SERB, France) was injected intravenously directly after induction of anesthesia, to obtain intraoperative near‐infrared fluorescence illumination of the extra‐hepatic bile ducts. Half of the patients received a repeat intravenous injection of 2.5mg of ICG at establishment of the Critical View of Safety for concomitant arterial and biliary fluorescence delineation. Fluorescence laparoscopy The operation was performed according to the Dutch Guidelines and Best Practice for laparoscopic cholecystectomy12, which is based on the CVS‐technique. Initial fluorescence cholangiography was conducted at the first view of the liver hilum. Subsequently, fluorescence imaging was applied every 5‐10 minutes until CVS was established by the surgeon. At establishment of CVS simultaneous fluorescence angiography was obtained from 10 seconds up to approximately 1 minute after repeat intravenous ICG injection. See Figure 4.1 for a flowchart of the study procedure. 54
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