早期胃癌患者腹腔镜前哨淋巴结导航保胃手术的随机临床试验

580 名术前诊断为 IA 期胃腺癌（≤3 cm）的患者被分配接受 LSG 或 LSNNS。观察者对患者分组不知情。主要结果是 3 年无病生存期 (3y-DFS)。次要结局包括术后并发症、生活质量、3 年疾病特异性生存率 (3y-DSS) 和 3 年总生存率 (3y-OS)。

总共有 527 名患者被纳入主要结局的改良意向治疗分析人群（LSG，269；LSNNS，258）。 LSNNS 组的 210 名患者 (81%) 接受了保胃手术。在中位随访期间，LSG 和 LSNNS 组的 3y-DFS 率分别为 95.5% 和 91.8%（差异：3.7%；95% CI，-0.6 至 8.1）。 LSNNS 组中 3 名复发患者和 5 名异时性胃癌患者接受了标准手术。两组均有2例远处转移患者接受姑息性化疗。 LSG 和 LSNNS 组的 3y-DSS 和 3y-OS 率分别为 99.5% 和 99.1% (P = .59) 和 99.2% 和 97.6% (P = .17)。 LSG 组和 LSNNS 组分别有 19.0% 和 15.5% 的术后并发症发生（P = .294）。 LSNNS 组表现出比 LSG 组更好的身体机能 (P = .015)、更少的症状 (P < .001) 和改善的营养。LSNNS 在 3y-DFS 方面未显示出与 LSG 的非劣效性，有 5% 的差值。然而，在复发/异时性胃癌的抢救手术后，3y-DSS 和 3y-OS 没有差异，并且 LSNNS 的长期生活质量和营养状况优于 LSG。

Abstract

Purpose: To compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).

Methods: Five hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).

Results: In total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, -0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% (P = .59) and 99.2% and 97.6% (P = .17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group (P = .294). The LSNNS group showed better physical function (P = .015), less symptoms (P < .001), and improved nutrition than the LSG group.

Conclusion: LSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.

原文链接：

https://ascopubs.org/doi/10.1200/JCO.21.02242?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

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