Chapter 4 procedures was calculated based on the video recordings, in order to objectify how much longer the operation lasted due to application of the fluorescence technique. Quantitative fluorescence image analysis For objective assessment of the degree of fluorescence illumination in the extra‐hepatic bile ducts and artery, OsiriX 5.5.1 Imaging Software was used. The fluorescence images were analyzed by determining target‐to‐background ratio (TBR). TBR was defined as the mean fluorescence intensity (FI) of two point regions of interest (ROIs) in the target (i.e. CBD, CD or CA) minus the mean fluorescence intensity of two background (BG) ROIs in the liver hilum, divided by the mean fluorescence intensity of the two background ROIs in the liver hilum; in formula: TBR = (FI of target ‐ FI of BG) / FI of BG. Statistical analysis Primary endpoint consisted of moment of clear visualization of the extra‐hepatic bile duct anatomy. Secondary endpoint was confirmation of the course of the cystic artery at establishment of CVS. Regarding the primary endpoint, a paired T‐test was applied for determination of possible significant differences between the time measurements from ‘introduction of laparoscope´ until ‘identification of CD / CBD’; comparing fluorescence imaging with conventional imaging. Results Thirty patients, undergoing an elective laparoscopic cholecystectomy, were included in this study. Before start of surgery no signs of biliary tract obstruction were present. Patient characteristics are shown in Table 4.1. Table 4.1 Patient characteristics No. of patients 30 Gender 11 male 56 19 female Age (y) 53 (26‐81) Body Mass Index (kg/m2) 26.7 (19.7‐36.8) Indication for surgery 20 cholecystolithiasis 8 cholecystitis 2 cholecystectomy after biliary pancreatitis ICG administration 2.5mg directly after induction of anesthesia (n=30) 2.5mg at establishment of CVS (n=15)
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