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荧光定量评估胃代食管术中胃管道血流灌注以减少食管癌切除术后吻合口漏:一项随机对照试验

Fluorescence quantitative assessment of blood perfusion in the gastric conduit to reduce anastomotic leakage after esophagectomy: a randomized controlled trial.

作者信息

He Wenwu, Li Zhiyu, Deng Xuyang, Zheng Kai, Wang Chenghao, Peng Lin, Han Yongtao, Leng Xuefeng, Zhou Qiuxi

机构信息

Department of Thoracic Surgery, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, China.

Department of Thoracic Surgery, The People's Hospital of Leshan, Leshan, China.

出版信息

Surg Endosc. 2025 Aug 20. doi: 10.1007/s00464-025-12093-6.

DOI:10.1007/s00464-025-12093-6
PMID:40835759
Abstract

OBJECTIVES

Indocyanine green (ICG) can help surgeons identify the blood perfusion distribution of the gastric conduit. The aim of our study is to utilize ICG fluorescence for quantitative assessment of blood perfusion at the anastomotic site to minimize postoperative anastomotic leakage.

METHODS

Patients who underwent McKeown esophagectomy with esophageal squamous cell carcinoma between August 1, 2019, and July 31, 2021, were enrolled in the study and randomly assigned to two groups. The intervention group received ICG fluorescence-guided anastomotic site selection. ICG fluorescence was used to quantitatively assess the blood perfusion fluorescence threshold at the anastomotic site in the gastric conduit, and anastomosis was performed only at sites where the fluorescence threshold exceeded the established threshold. In the control group, anastomosis was conducted at the visually evaluated site determined by the surgeon's experience.

RESULTS

45 eligible patients were assigned to the intervention group, and 47 patients were allocated to the control group, respectively. Anastomotic leakage within 30 days occurred in 6.7% (3/45) of the intervention group and in 21.3% (10/47) of the control group (p = 0.021). Additionally, no differences were observed in anastomotic stenosis within 90 days, overall survival time or in the effect of neoadjuvant therapy on anastomotic leakage.

CONCLUSION

ICG fluorescence can identify the areas with good perfusion in the gastric conduit and significantly reduce the occurrence of anastomotic leakage following esophagectomy.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04229524.

摘要

目的

吲哚菁绿(ICG)可帮助外科医生识别胃管道的血液灌注分布。本研究的目的是利用ICG荧光对吻合口部位的血液灌注进行定量评估,以尽量减少术后吻合口漏。

方法

选取2019年8月1日至2021年7月31日期间接受McKeown食管癌切除术的食管鳞状细胞癌患者纳入研究,并随机分为两组。干预组接受ICG荧光引导下的吻合口部位选择。使用ICG荧光定量评估胃管道吻合口部位的血液灌注荧光阈值,仅在荧光阈值超过既定阈值的部位进行吻合。对照组在由外科医生经验确定的视觉评估部位进行吻合。

结果

分别有45例符合条件的患者被分配到干预组,47例患者被分配到对照组。干预组30天内吻合口漏发生率为6.7%(3/45),对照组为21.3%(10/47)(p = 0.021)。此外,90天内吻合口狭窄、总生存时间或新辅助治疗对吻合口漏的影响方面未观察到差异。

结论

ICG荧光可识别胃管道中灌注良好的区域,并显著降低食管癌切除术后吻合口漏的发生率。

试验注册

ClinicalTrials.gov标识符:NCT04229524。

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本文引用的文献

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Does Indocyanine Green Utilization during Esophagectomy Prevent Anastomotic Leaks? Systematic Review and Meta-Analysis.食管癌切除术中使用吲哚菁绿能否预防吻合口漏?系统评价与Meta分析。
J Clin Med. 2024 Aug 20;13(16):4899. doi: 10.3390/jcm13164899.
2
Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial.吲哚菁绿荧光成像引导的微创直肠癌手术中的血流灌注评估(EssentiAL 试验):一项随机临床试验。
Ann Surg. 2023 Oct 1;278(4):e688-e694. doi: 10.1097/SLA.0000000000005907. Epub 2023 May 23.
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Current Trends in Volume and Surgical Outcomes in Gastric Cancer.
胃癌手术量及手术结果的当前趋势
J Clin Med. 2023 Apr 4;12(7):2708. doi: 10.3390/jcm12072708.
4
Quantitative perfusion assessment using indocyanine green during surgery - current applications and recommendations for future use.术中使用吲哚菁绿进行定量灌注评估——当前的应用和未来使用的建议。
Langenbecks Arch Surg. 2023 Jan 26;408(1):67. doi: 10.1007/s00423-023-02780-0.
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Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.试验报告中结果报告指南:CONSORT-结果2022扩展版
JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.
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The ISCON-trial protocol: laparoscopic ischemic conditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications.ISCON 试验方案:在伴有动脉钙化的食管癌患者中,行食管切除术前行腹腔镜缺血预处理。
BMC Cancer. 2022 Feb 5;22(1):144. doi: 10.1186/s12885-022-09231-x.
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The impact of cervical anastomotic leak after esophagectomy on long-term survival of patients with esophageal cancer.食管癌切除术后颈部吻合口漏对患者长期生存的影响。
Surgery. 2022 May;171(5):1257-1262. doi: 10.1016/j.surg.2021.10.011. Epub 2021 Nov 6.
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Response to the Comment on "The Effect of Postoperative Complications After Minimally Invasive Esophagectomy on Long-term Survival: An International Multicenter Cohort Study".对《微创食管切除术后并发症对长期生存的影响:一项国际多中心队列研究》评论的回应
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Quantification of fluorescence angiography: Toward a reliable intraoperative assessment of tissue perfusion - A narrative review.荧光血管造影定量分析:实现组织灌注术中可靠评估的方法——叙述性综述。
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