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.
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.