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吲哚菁绿引导下腹腔镜局部进展期胃癌淋巴结清扫术的安全性和有效性:CLASS-11临床试验

Safety and efficacy of indocyanine green-guided laparoscopic lymphadenectomy for locally advanced gastric cancer: The CLASS-11 clinical trials.

作者信息

Zheng Chao-Hui, Chen Ying-Bo, Yu Wen-Bin, Cai Li-Sheng, Wang Quan, Sun Yi-Hong, Yan Su, He Xian-Li, Xu Ze-Kuan, Li Guo-Xin, Tian Yan-Tao, Li Chen, Wang Bao-Gui, Ji Jia-Fu, Xu Yan-Chang, Zhong Qing, Liu Zhi-Yu, Chen Qi-Yue, Li Ping, Xie Jian-Wei, Liang Yao, Liu Zhi-Min, Qiu Hai-Bo, Wei Meng, Yan Zhi-Bo, Lv Chen-Bin, Chen Qiu-Xian, Li Shuang, Zeng Ling-Xiao, Huo Bo-Wen, Li Zi-Yu, Su Xiang-Qian, Huang Chang-Ming

机构信息

Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.

Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.

出版信息

Cell Rep Med. 2025 May 20;6(5):102136. doi: 10.1016/j.xcrm.2025.102136.

DOI:10.1016/j.xcrm.2025.102136
PMID:40398388
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12147906/
Abstract

We report the short-term results of indocyanine green (ICG)-guided laparoscopic lymphadenectomy for gastric cancer (GC). The primary outcome is 3-year disease-free survival. In this analysis, we present short-term secondary outcomes focused on the number of lymph nodes (LNs) retrieved and the diagnostic value of fluorescent status for metastatic LNs, excluding long-term outcomes. A total of 1,006 patients are included in the per-protocol analysis. The mean number of LNs retrieved in the ICG group is significantly higher than that in the non-ICG group. The negative predictive value is 93.9% for nonfluorescent stations, and the sensitivity of ICG for detecting all metastatic LN stations is 91.6%. ICG technology is safe and feasible for laparoscopic lymphadenectomy in GC and can noticeably increase the number of LNs retrieved. Further follow-up is necessary to warrant whether ICG can improve long-term survival of GC. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS)-11 trial has been registered at ClinicalTrials.gov as NCT04593615.

摘要

我们报告了吲哚菁绿(ICG)引导下的腹腔镜胃癌淋巴结清扫术的短期结果。主要结局是3年无病生存率。在本分析中,我们呈现聚焦于获取的淋巴结数量以及荧光状态对转移淋巴结的诊断价值的短期次要结局,不包括长期结局。共有1006例患者纳入符合方案分析。ICG组获取的淋巴结平均数量显著高于非ICG组。非荧光区域的阴性预测值为93.9%,ICG检测所有转移淋巴结区域的敏感性为91.6%。ICG技术对于腹腔镜胃癌淋巴结清扫术是安全可行且能显著增加获取的淋巴结数量。需要进一步随访以确定ICG是否能改善胃癌患者的长期生存。中国腹腔镜胃肠外科研究(CLASS)-11试验已在ClinicalTrials.gov注册,注册号为NCT04593615。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/c843ba38ddfc/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/8c004d814cfe/fx1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/394d9872b117/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/5cc78b8b8c23/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/c843ba38ddfc/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/8c004d814cfe/fx1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/394d9872b117/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/5cc78b8b8c23/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bbdb/12147906/c843ba38ddfc/gr3.jpg

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本文引用的文献

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Assessment of Laparoscopic Indocyanine Green Tracer-guided Lymphadenectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Controlled Trial.腹腔镜吲哚菁绿示踪剂引导新辅助化疗后局部进展期胃癌淋巴结清扫术评估:一项随机对照试验。
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Indocyanine green fluorescence imaging-guided versus conventional laparoscopic lymphadenectomy for gastric cancer: long-term outcomes of a phase 3 randomised clinical trial.
吲哚菁绿荧光成像引导与传统腹腔镜淋 巴结切除术治疗胃癌:一项 3 期随机临床试验的长期结果。
Nat Commun. 2023 Nov 16;14(1):7413. doi: 10.1038/s41467-023-42712-6.
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Indocyanine Green Fluorescence-Guided Surgery for Gastrointestinal Tumors: A Systematic Review.吲哚菁绿荧光引导下的胃肠道肿瘤手术:一项系统评价。
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Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer: The JLSSG0901 Randomized Clinical Trial.腹腔镜辅助与开腹远端胃癌根治术治疗进展期胃癌的 5 年生存结局:JLSSG0901 随机临床试验。
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