比较腹腔镜前哨淋巴结导航手术(LSNNS)和腹腔镜标准胃切除术(LSG)的术后并发症、长期生存率和生活质量(QOL)。

580名术前诊断为IA期胃腺癌(≤ 3 cm)的患者被分配接受LSG或淋巴结清扫术。观察者对患者分组并不盲目。主要结果是3年无病生存期(3y-DFS)。次要转归包括术后并发症、QOL、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果的改良意向性治疗分析人群(LSG，269；LSNNS，258)。LSNNS组中有210例(81%)患者进行了保胃手术。在中位随访期间，LSG组和LSNNS组的3y-DFS率分别为95.5%和91.8%(差异:3.7%；95%可信区间，-0.6至8.1)。LSNNS组中3例复发患者和5例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组和淋巴结核组的3y-DSS和3y-OS率分别为99.5%和99.1%(P = 0.59)以及99.2%和97.6%(P = 0.17)。术后并发症在LSG组发生率为19.0%，在LSNNS组发生率为15.5%(P = 0.294)。与LSG组相比，LSNNS组表现出更好的身体功能(P = .015)、更少的症状(P < .001)和更好的营养。对于3年DFS，LSNNS没有表现出相对于LSG的非劣效性，有5%的裕度。然而，在复发/异时性胃癌病例中，救援手术后3y-DSS和3y-OS没有差异，并且LSNNS比LSG具有更好的长期QOL和营养。

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

pubmed.ncbi.nlm.nih.gov/35324317/

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