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腹腔镜胆囊切除术中使用吲哚菁绿的实时荧光胆管造影:一项术前30分钟内确定最佳吲哚菁绿剂量的随机对照试验

Real-time fluorescent cholangiography with indocyanine green in laparoscopic cholecystectomy: a randomized controlled trial to establish the optimal indocyanine green dose within 30 min preoperatively.

作者信息

Huang Yu, Chen Qiangxing, Kuang Jiao, Zhang Shuai, Weng Jiefeng, Lai Yueyuan, Liu Hui, Wu Zhaofeng, Huang Di, Lin Fan, Zhu Guanghui, Cao Tiansheng, Gu Weili

机构信息

Department of Surgery, Guangzhou First People's Hospital, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.

Department of Surgery, Huadu District People's Hospital of Guangzhou, No.48 Xinhua Road, Xinhua Street, Huadu District, Guangzhou, 510180, Guangdong, China.

出版信息

Surg Today. 2023 Feb;53(2):223-231. doi: 10.1007/s00595-022-02563-y. Epub 2022 Aug 3.

DOI:10.1007/s00595-022-02563-y
PMID:35920936
Abstract

PURPOSE

To establish the optimal dose of indocyanine green (ICG) to administer intravenously 30 min before laparoscopic cholecystectomy (LC).

METHODS

In this randomized controlled trial (RCT), patients undergoing LC for cholecystitis, cholelithiasis, and/or cholecystic polyps were randomized into four groups given four different ICG doses (0.025, 0.1, 0.25, 2.5 mg). Using OptoMedic endoscopy combined with a near-infrared fluorescent imaging system, we evaluated the fluorescence intensity (FI) of the common bile duct and liver at three timepoints: before surgical dissection of the cystohepatic triangle, before clipping of the cystic duct, and before closure. The bile duct-to-liver ratio (BLR) of the FI was analyzed to assess the cholangiography effect.

RESULTS

Sixty-four patients were allocated to one of four groups, with 40 patients included in the final analysis. Generally, with increasing ICG doses, the levels of FI in the bile duct and liver increased gradually at each of the three timepoints. Before surgical dissection of the cystohepatic triangle, 0.1-mg ICG showed the highest BLR (F = 3.47, p = 0.0259). Before clipping the cystic duct and before closure, the 0.025- and 0.1-mg groups showed a higher BLR than the 0.25- and 2.5-mg groups (p < 0.05). When setting the ideal cholangiography at a BLR ≥ 1, ≥ 3, or ≥ 5, the 0.1-mg group showed the highest qualified case number at the three timepoints.

CONCLUSIONS

The intravenous administration of 0.1-mg ICG, 30 min before LC, is significantly better for fluorescent cholangiography of the extrahepatic biliary structures before dissection and clipping of the cystohepatic triangle.

TRIAL REGISTRATION

This study was registered in the Chinese Clinical Trial Registry (ChiCTR) (ChiCTR2200057933).

摘要

目的

确定在腹腔镜胆囊切除术(LC)前30分钟静脉注射吲哚菁绿(ICG)的最佳剂量。

方法

在这项随机对照试验(RCT)中,因胆囊炎、胆结石和/或胆囊息肉接受LC的患者被随机分为四组,给予四种不同剂量的ICG(0.025、0.1、0.25、2.5毫克)。使用OptoMedic内窥镜结合近红外荧光成像系统,我们在三个时间点评估胆总管和肝脏的荧光强度(FI):在肝囊肿三角手术解剖前、胆囊管夹闭前和关闭前。分析FI的胆管与肝脏比率(BLR)以评估胆管造影效果。

结果

64例患者被分配到四组中的一组,最终分析纳入40例患者。一般来说,随着ICG剂量增加,在三个时间点的每个时间点,胆管和肝脏中的FI水平逐渐升高。在肝囊肿三角手术解剖前,0.1毫克ICG显示出最高的BLR(F = 3.47,p = 0.0259)。在夹闭胆囊管前和关闭前,0.025毫克和0.1毫克组的BLR高于0.25毫克和2.5毫克组(p < 0.05)。当将理想胆管造影的BLR设定为≥1、≥3或≥5时,0.1毫克组在三个时间点显示出最高的合格病例数。

结论

在LC前30分钟静脉注射0.1毫克ICG,对于肝外胆管结构在解剖和夹闭肝囊肿三角前的荧光胆管造影明显更好。

试验注册

本研究在中国临床试验注册中心(ChiCTR)注册(ChiCTR2200057933)。

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