吲哚菁绿荧光胆道即时显影技术的参数优化及临床应用价值：一项前瞻性随机对照研究

Parameter Optimization and Clinical Application Value of Indocyanine Green Fluorescence Real-Time Biliary Imaging Technology: A Prospective Randomized Controlled Study

摘要: 本研究通过一项前瞻性随机对照试验，系统优化了吲哚菁绿即时荧光胆道显影技术在腹腔镜胆囊切除术中的关键参数，并评估其临床应用价值。研究将160例患者随机分组，重点探讨了静脉注射的四种不同剂量(0.125 mg、0.25 mg、0.5 mg及1.0 mg)、两种术前给药时机(术前15分钟与30分钟)，以及术中经胆囊直接注射这一替代途径的显影效果。结果表明，静脉注射0.5 mg吲哚菁绿并结合20至30分钟的等待时间可实现最佳的胆道显影效果，其胆囊管与胆总管连接处的显影最为清晰且对比度高。相比之下，经胆囊直接注射虽能将显影时间缩短至约2.6分钟，并获得100%的显影成功率，但存在7.5%的示踪剂泄漏风险，可能导致手术视野污染。本研究最终证实，该荧光显影技术安全有效，并为其制定了针对常规与复杂手术情景的个体化方案：静脉给药作为标准方案适用于计划性手术，而术中直接注射可作为困难解剖病例的快速备份方案，从而在整体上显著提升手术安全性并降低胆管损伤风险。

Abstract: This prospective randomized controlled trial aimed to optimize the key parameters of indocyanine green real-time fluorescence cholangiography and evaluate its clinical utility in laparoscopic cholecystectomy. A total of 160 patients were randomized to investigate the effects of different intravenous ICG doses, administration timings, and an intraoperative direct gallbladder injection approach. The results indicated that intravenous injection of 0.5 mg ICG with a 20 to 30-minute waiting period provided optimal biliary duct visualization, demonstrating clear imaging of the cystic duct-common bile duct junction with high contrast. In comparison, while direct gallbladder injection achieved rapid visualization within approximately 2.6 minutes and a 100% success rate, it was associated with a 7.5% risk of ICG leakage and potential surgical field contamination. This study confirms that ICG fluorescence imaging is a safe and effective technique. It establishes a personalized protocol where intravenous administration is recommended for standard procedures, and direct gallbladder injection serves as a valuable backup for cases with complex anatomy, thereby significantly enhancing surgical safety and reducing the risk of bile duct injury.