Abstract：
OBJECTIVE: Intraoperative bile duct injury is a significant complication in laparoscopic cholecystectomy (LC). Near-infrared fluorescence cholangiography (NIFC) can reduce this complication. Therefore, determining the optimal indocyanine green (ICG) dosage for effective NIFC is crucial. This study aimed to determine the optimal ICG dosage for NIFC.
METHODS: This was a prospective, randomized, double-blind clinical trial at a single tertiary referral center, including 195 patients randomly assigned to three groups: lower dose (0.01 mg/BMI) ICG (n = 63), medium dose (0.02 mg/BMI) ICG (n = 68), and higher dose (0.04 mg/BMI) ICG (n = 64). Surgeon satisfaction and detection rates for seven biliary structures were compared among the three dose groups.
RESULTS: Demographic parameters did not significantly differ among the groups. The medium dose (72.1%) and higher dose ICG groups (70.3%) exhibited superior visualization of the common hepatic duct compared to the lower dose group (41.3%) (p < 0.001). No differences existed between the medium and higher dose groups. Similar trends were observed for the common bile duct and cystic common bile duct junction.
CONCLUSIONS: In patients undergoing fluorescent laparoscopic cholecystectomy, the 0.02 mg/BMI dose of indocyanine green demonstrated better biliary structure detection rates than the 0.01 mg/BMI dose and was non-inferior to the 0.04 mg/BMI dose.
METHODS: This was a prospective, randomized, double-blind clinical trial at a single tertiary referral center, including 195 patients randomly assigned to three groups: lower dose (0.01 mg/BMI) ICG (n = 63), medium dose (0.02 mg/BMI) ICG (n = 68), and higher dose (0.04 mg/BMI) ICG (n = 64). Surgeon satisfaction and detection rates for seven biliary structures were compared among the three dose groups.
RESULTS: Demographic parameters did not significantly differ among the groups. The medium dose (72.1%) and higher dose ICG groups (70.3%) exhibited superior visualization of the common hepatic duct compared to the lower dose group (41.3%) (p < 0.001). No differences existed between the medium and higher dose groups. Similar trends were observed for the common bile duct and cystic common bile duct junction.
CONCLUSIONS: In patients undergoing fluorescent laparoscopic cholecystectomy, the 0.02 mg/BMI dose of indocyanine green demonstrated better biliary structure detection rates than the 0.01 mg/BMI dose and was non-inferior to the 0.04 mg/BMI dose.
摘要：
目的：术中胆管损伤是腹腔镜胆囊切除术（LC）的重要并发症。近红外荧光胆管造影（NIFC）可以减少这种并发症。因此,确定最佳吲哚菁绿(ICG)剂量对有效的NIFC至关重要。本研究旨在确定用于NIFC的最佳ICG剂量。
方法：这是一个前瞻性的，随机化，在单一三级转诊中心进行的双盲临床试验，包括195名患者，随机分为三组：低剂量（0.01mg/BMI）ICG（n=63），中等剂量（0.02mg/BMI）ICG（n=68），和更高剂量（0.04mg/BMI）ICG（n=64）。比较三个剂量组的外科医生满意度和七个胆道结构的检出率。
结果：各组人口统计学参数没有显著差异。与低剂量组（41.3％）相比，中等剂量（72.1％）和较高剂量ICG组（70.3％）表现出更高的肝总管可视化（p<0.001）。在中等和较高剂量组之间不存在差异。在胆总管和囊性胆总管交界处观察到类似的趋势。
结论：在接受荧光腹腔镜胆囊切除术的患者中，0.02mg/BMI剂量的吲哚菁绿显示出比0.01mg/BMI剂量更好的胆道结构检出率,并且不劣于0.04mg/BMI剂量.
方法：这是一个前瞻性的，随机化，在单一三级转诊中心进行的双盲临床试验，包括195名患者，随机分为三组：低剂量（0.01mg/BMI）ICG（n=63），中等剂量（0.02mg/BMI）ICG（n=68），和更高剂量（0.04mg/BMI）ICG（n=64）。比较三个剂量组的外科医生满意度和七个胆道结构的检出率。
结果：各组人口统计学参数没有显著差异。与低剂量组（41.3％）相比，中等剂量（72.1％）和较高剂量ICG组（70.3％）表现出更高的肝总管可视化（p<0.001）。在中等和较高剂量组之间不存在差异。在胆总管和囊性胆总管交界处观察到类似的趋势。
结论：在接受荧光腹腔镜胆囊切除术的患者中，0.02mg/BMI剂量的吲哚菁绿显示出比0.01mg/BMI剂量更好的胆道结构检出率,并且不劣于0.04mg/BMI剂量.
