Upper GI Surgery and HPB Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Ann Surg Oncol. 2023 Oct;30(11):6803-6811. doi: 10.1245/s10434-023-13848-y. Epub 2023 Jul 13.
Indocyanine green (ICG)-guided lymphadenectomy using near-infrared visualization (NIR) may increase nodal yield during gastrectomy. The purpose of this study was to evaluate the clinical benefit of NIR visualization on the quality of D2 lymphadenectomy during laparoscopic distal gastrectomy.
This single-arm, open-label, Simon's two-stage, adaptive, phase 2 trial included patients who underwent laparoscopic distal gastrectomy for gastric adenocarcinoma. Endoscopic peritumoral injection of ICG was performed 24 ± 6 h before surgery. Intraoperatively, after standard D2 lymphadenectomy and specimen extraction, NIR was used for eventual completion lymphadenectomy. The primary endpoint was clinical benefit of NIR (i.e., at least one additional harvested station containing lymph nodes, with negative points for every harvested station with no lymph nodes at final pathology).
We enrolled 18 patients (61% female, median age 69 years). With NIR, an extra 23 stations were harvested: 9 contained no lymph nodes, 12 contained nonmetastatic lymph nodes, and 2 contained metastatic lymph nodes. The most commonly visualized station with NIR were station 6 (8 patients) and 1 (4 patients). The total number of harvested nodes per patient was 32 (interquartile range [IQR] 26-41), with a median of 1 (IQR 0-1) additional lymph node after NIR. Overall, seven (39%) patients had a clinical benefit from NIR, of which two (11%) had one metastatic lymph node harvested with NIR.
NIR visualization improves the quality of D2 lymphadenectomy in distal gastrectomy for gastric cancer. Considering the limited improve in the number of harvested lymph nodes, its real oncological benefit is still questionable.
近红外可视化（NIR）引导下的吲哚菁绿（ICG）淋巴结切除术可能会增加胃癌根治术中淋巴结的检出数量。本研究旨在评估 NIR 可视化对腹腔镜远端胃癌根治术中 D2 淋巴结清扫质量的临床获益。
这是一项单臂、开放标签、Simon 两阶段、适应性、2 期临床试验，纳入了接受腹腔镜远端胃癌切除术治疗胃腺癌的患者。术前 24 ± 6 小时行内镜下肿瘤周围注射 ICG。术中在标准 D2 淋巴结清扫和标本取出后，使用 NIR 进行最终的完成性淋巴结清扫。主要终点是 NIR 的临床获益（即至少额外检出一个含有淋巴结的清扫站，对于每个最终病理检查无淋巴结的清扫站计为阴性点）。
共纳入 18 例患者（61%为女性，中位年龄 69 岁）。使用 NIR 额外检出了 23 个站：9 个站未检出淋巴结，12 个站检出非转移性淋巴结，2 个站检出转移性淋巴结。最常见的 NIR 可视化站是 6 站（8 例患者）和 1 站（4 例患者）。每位患者的总检出淋巴结数为 32 个（四分位距 [IQR] 26-41），NIR 后中位数增加 1 个（IQR 0-1）淋巴结。总体而言，7 例（39%）患者从 NIR 中获益，其中 2 例（11%）患者检出 1 个转移性淋巴结。
NIR 可视化可改善胃癌腹腔镜远端胃切除术中 D2 淋巴结清扫的质量。考虑到检出淋巴结数量的有限改善，其真正的肿瘤学获益仍值得商榷。
