探讨ERCP胆道显影中ICG最佳剂量和荧光强度、显影率之间的效应关系。

本前瞻性研究对象为2023年12月至2024年10月在广东医科大学附属第二医院行ERCP并留置鼻胆管的36例胆总管结石患者。其中男21例，女15例；年龄22~89岁，中位年龄68岁。患者均签署知情同意书，符合医学伦理学规定。将入组患者随机分成3组，在术后拔除鼻胆管前30 min经过外周静脉缓慢注射ICG，ICG剂量分别为0.30、0.35、0.40 mg/kg。通过内窥镜荧光摄像系统采集胆汁图片，应用ImageJ软件对所采集的图像进行荧光强度的测定，计算该患者对应剂量的荧光强度、显影率等。对荧光效果进行视觉模拟评分（VAS）客观评价。相关性分析采用Pearson直线相关分析。采用ROC曲线分析荧光强度及VAS评分诊断价值等。

0.30、0.35、0.40 mg/kg组患者30 min胆管显影分别为8、12、11例，差异有统计学意义（χ²=6.039，P=0.040）；荧光强度分别为70±9、99±13、97±16，荧光强度差异亦有统计学意义（F=18.93，P<0.01）。0.35 mg/kg组给药30 min后显影率为100%。荧光强度与剂量呈正相关（r=0.619，P<0.01）。对荧光效果进行的VAS评价显示，静脉注射ICG剂量为0.35 mg/kg和0.40 mg/kg时，100%患者可达到直观以上的显示效果；0.30 mg/kg时，60%达到直观以上显示效果。ROC曲线分析显示，胆汁中ICG荧光强度的AUC为0.942（95%CI：0.850~1.000，P<0.01），灵敏度为0.774，特异度为1.000；荧光效果VAS评价的AUC为0.735（95%CI：0.483~0.988，P>0.05），灵敏度为0.968，特异度为0.400。

ICG在ERCP胆道显影中的最佳静脉注射剂量为0.35~0.40 mg/kg，在胆汁中可以达到最佳的显影率及荧光效果，其荧光强度具有较好的诊断价值。

To investigate the relationship between the optimal dose of indocyanine green (ICG) and the fluorescence intensity and development rate in endoscopic retrograde cholangiopancreatography (ERCP).

Thirty-six patients with common bile duct stones undergoing ERCP and indwelling nasobiliary drainage in the Second Affiliated Hospital of Guangdong Medical University from December 2023 to October 2024 were enrolled in this prospective study. Among them, 21 patients were male and 15 female, aged from 22 to 89 years, with a median age of 68 years.The informed consents of all patients were obtained and the local ethical committee approval was received. All patients were randomly divided into three groups. ICG was intravenously injected slowly at a dose of 0.30, 0.35 and 0.40 mg/kg at 30 min before postoperative removal of nasobiliary drainage, respectively. Bile images were collected by endoscopic fluorescence camera system. The fluorescence intensity of the collected images was measured by Image J software, and the fluorescence intensity and development rate at corresponding dose of the patient were calculated. The fluorescence effect was evaluated objectively by visual analogue scale (VAS). Correlation analysis was performed by Pearson linear correlation. The diagnostic value of fluorescence intensity and VAS score was assessed by receiver operating characteristic (ROC) curve.

In the 0.30 mg/kg, 0.35 mg/kg and 0.40 mg/kg dose groups, 8, 12 and 11 cases experienced 30-min development of bile ducts, and the differences were statistically significant(χ²=6.039, P=0.040), and the fluorescence intensities were 70±9, 99±13 and 97±16, and the differences were also statistically significant (F=18.93, P<0.01). The 30-min visualization rate in the 0.35 mg/kg group was 100%. The ICG fluorescence intensity and dose were positively correlated (r=0.619, P<0.01). The VAS evaluation showed that at intravenous ICG doses of 0.35 mg/kg and 0.40 mg/kg, 100% of patients achieved visualization above the intuitive level; at 0.30 mg/kg, 60% achieved visualization above that level. ROC curve analysis showed that the area under the ROC curve (AUC) of ICG fluorescence intensity in bile was 0.942 (95%CI: 0.850-1.000, P<0.01), the sensitivity was 0.774 and the specificity was 1.000, respectively. The AUC of VAS score of fluorescence effect was 0.735 (95%CI: 0.483-0.988, P>0.05), the sensitivity was 0.968 and the specificity was 0.400, respectively.

The optimal intravenous dose of ICG in ERCP is ranged from 0.35 to 0.40 mg/kg, which can achieve the optimal development rate and fluorescence effect in bile. The fluorescence intensity yields good diagnostic value.