Zhang Yu, Li Ziyu, Tian Yantao, Yu Jiang, Wang Jieti, Lee Changmin, Wang Kuan, He Xianli, Qiao Qing, Ji Gang, Xu Zekuan, Yang Li, Xu Hao, Du Xiaohui, Su Xiangqian, Xing Jiadi, Niu Zhaojian, Zhu Linghua, Yan Su, Li Yong, Wang Junjiang, Li Zhengrong, Zhao Yongliang, You Jun, Jing Changqing, Fan Lin, Du Yian, Zhao Gaoping, Song Wu, Xuan Yi, Zang Mingde, Chen Jie, Park Sungsoo, Huang Hua
Department of Gastric Surgery, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, People's Republic of China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
Gastric Cancer. 2025 Jan;28(1):131-144. doi: 10.1007/s10120-024-01561-y. Epub 2024 Nov 5.
There is a paucity of confirmatory randomized controlled trials (RCTs) comparing the effectiveness of totally laparoscopic distal gastrectomy (TLDG) vs laparoscopy-assisted distal gastrectomy (LADG) for early gastric cancer (EGC).
A phase III, prospective, multi-center RCT was conducted, wherein patients (n = 442) with clinical stage I gastric cancer eligible for laparoscopic distal gastrectomy were randomized 1:1 to the TLDG or the LADG group. Postoperative morbidity and quality of life (QoL) were compared.
In total, 422 patients were assessed (TLDG, 216; LADG, 206) in the modified intention-to-treat (mITT) analysis. The morbidity rate did not differ significantly between the two groups (TLDG, 6.0%; LADG, 5.8%; P = 0.93). The 90-day mortality rate was comparable between the groups (TLDG, 0.5%; LADG, 0.0%; P > 0.99). TLDG was significantly associated with a lower pain score compared with LADG in patients with a BMI of ≥ 25 kg/m (P = 0.002) at 24 h postoperatively. Moreover, TLDG significantly improved QoL in terms of C30 social functioning at 3 and 6 months (P = 0.03 and P = 0.04), C30 global health status at 3 months (P = 0.02), and STO22 body image at 3 months (P = 0.01), with differences dissipating at 12 months.
TLDG is not superior to LADG in terms of postoperative morbidity and mortality, but it provides better C30 social functioning at 3 and 6 months, C30 global health status and STO22 body image at 3 months, and reduces early postoperative pain for patients with a BMI of ≥ 25 kg/m.
ClinicalTrials.gov: NCT03393182.
比较完全腹腔镜下远端胃癌切除术（TLDG）与腹腔镜辅助远端胃癌切除术（LADG）治疗早期胃癌（EGC）疗效的验证性随机对照试验（RCT）较少。
开展一项III期前瞻性多中心RCT，将符合腹腔镜远端胃癌切除术条件的临床I期胃癌患者（n = 442）按1:1随机分为TLDG组或LADG组。比较术后发病率和生活质量（QoL）。
在改良意向性分析（mITT）中，共评估了422例患者（TLDG组216例，LADG组206例）。两组的发病率无显著差异（TLDG组为6.0%，LADG组为5.8%；P = 0.93）。两组的90天死亡率相当（TLDG组为0.5%，LADG组为0.0%；P > 0.99）。术后24小时，BMI≥25 kg/m²的患者中，TLDG组的疼痛评分显著低于LADG组（P = 0.002）。此外，TLDG在3个月和6个月时在C30社会功能方面显著改善了QoL（P = 0.03和P = 0.04），在3个月时C30总体健康状况方面（P = 0.02），以及在3个月时STO22身体形象方面（P = 0.01），这些差异在12个月时消失。
TLDG在术后发病率和死亡率方面并不优于LADG，但在3个月和6个月时能提供更好的C30社会功能，在3个月时能提供更好的C30总体健康状况和STO22身体形象，并且能减轻BMI≥25 kg/m²患者的术后早期疼痛。
ClinicalTrials.gov：NCT03393182。
