Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing, 100142, China.
Department of General Surgery, Beijing Key Laboratory of Cancer Invasion and Metastasis Research & National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.
Surg Endosc. 2019 Jan;33(1):33-45. doi: 10.1007/s00464-018-6391-x. Epub 2018 Nov 1.
Although laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data. To evaluate the efficacy of LADG, we conducted a multi-institutional randomized controlled trial to compare laparoscopy-assisted versus open distal gastrectomy (ODG) for AGC in North China.
In this RCT, after patients were enrolled according to the eligibility criteria, they were preoperatively assigned to LADG or ODG arm randomly with a 1:1 allocation ratio. The primary endpoint was the morbidity and mortality within 30 postoperative days to evaluate the surgical safety of LADG. The secondary endpoint was 3-year disease-free survival. This trial was registered at ClinicalTrial.gov as NCT02464215.
Between March 2014 and August 2017, a total of 446 patients with cT2-4aN0-3M0 (AJCC 7th staging system) were enrolled. Of these, 222 patients underwent LADG and 220 patients underwent ODG were included in the modified intention-to-treat analysis. The compliance rate of D2 lymph node dissection was identical between the LADG and ODG arms (99.5%, P = 1.000). No significant difference was observed regarding the overall postoperative complication rate in two groups (LADG 13.1%, ODG 17.7%, P = 0.174). No operation-related death occurred in both arms.
This trial confirmed that LADG performed by credentialed surgeons was safe and feasible for patients with AGC compared with conventional ODG.
虽然腹腔镜手术已被推荐作为早期胃癌患者的可选治疗方法，但由于缺乏全面的临床数据，局部进展期胃癌（AGC）患者是否能从腹腔镜辅助远端胃切除术（LADG）联合 D2 淋巴结清扫中获益仍不清楚。为了评估 LADG 的疗效，我们进行了一项多中心随机对照试验，比较了中国北方地区 LADG 与开腹远端胃切除术（ODG）治疗 AGC 的疗效。
在这项 RCT 中，患者符合纳入标准后，按照 1:1 的比例被随机分配到 LADG 或 ODG 组。主要终点是术后 30 天内的发病率和死亡率，以评估 LADG 的手术安全性。次要终点是 3 年无病生存率。本试验在 ClinicalTrials.gov 注册，编号为 NCT02464215。
2014 年 3 月至 2017 年 8 月，共纳入 446 例 cT2-4aN0-3M0（第 7 版 AJCC 分期系统）的患者。其中，222 例行 LADG，220 例行 ODG，均纳入改良意向治疗分析。两组 D2 淋巴结清扫的符合率相同（99.5%，P=1.000）。两组总体术后并发症发生率无显著差异（LADG 组 13.1%，ODG 组 17.7%，P=0.174）。两组均无手术相关死亡。
本试验证实，对于 AGC 患者，经验丰富的外科医生行 LADG 与传统 ODG 相比是安全可行的。
