Department of Surgery, Fujita Health University, 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan.
Department of Advanced Robotic and Endoscopic Surgery, Fujita Health University, 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan.
Surg Endosc. 2024 Oct;38(10):5693-5703. doi: 10.1007/s00464-024-11153-7. Epub 2024 Aug 12.
This study aimed to investigate the laparoscopic gastrectomy (LG) performance of non-Endoscopic Surgical Skill Qualification System (ESSQS)-qualified surgeons under the ESSQS-qualified surgeon guidance and compare oncological outcomes of gastric cancer to LG performed by the ESSQS-qualified surgeons.
This study enrolled 1,030 patients diagnosed with both clinical and pathological stage ≤ III gastric cancer and undergoing LG from January 2009 to June 2019. ESSQS-qualified surgeons served as the operator or the instructive assistant in all LG procedures involving them. A propensity score-matched analysis was used to retrospectively compare the long-term outcomes between the ESSQS-qualified and non-ESSQS-qualified surgeons.
Each group included 315 pairs after propensity score matching. The 3-year recurrence-free survival rates were 84.4% and 81.7% in the non-ESSQS and ESSQS groups, respectively. The difference was 2.7% (95% confidence interval: - 3.20%-8.44%, P < 0.001), and the non-ESSQS group statistically demonstrated noninferiority as the lower 95% confidence limit was greater than the prespecified margin of -10%, indicating the achieved primary endpoint. No significant differences in 5-year recurrence-free survival (non-ESSQS: 78.5% vs. ESSQS: 77.4%, P = 0.627) and 5-year overall survival (non-ESSQS: 80.9% vs. ESSQS: 79.3%, P = 0.475) were found between the two groups. The oncological outcomes stratified according to the presence of pathological stage I, II, and III disease did not significantly differ between the two groups.
LG performed by non-ESSQS-qualified surgeons achieved comparable oncological outcomes to the ESSQS-qualified surgeons, as long as ESSQS-qualified surgeons provided intraoperative instructions, in a high-volume center.
本研究旨在探讨在有经验的外科医生指导下,非内镜手术技能资格认证系统(ESSQS)认证外科医生行腹腔镜胃切除术(LG)的表现,并比较其与 ESSQS 认证外科医生行 LG 的胃癌患者的肿瘤学结局。
本研究纳入了 2009 年 1 月至 2019 年 6 月期间,经临床和病理分期均≤III 期的胃癌患者 1030 例,所有 LG 手术均由 ESSQS 认证外科医生担任术者或指导助手。采用倾向评分匹配分析,回顾性比较 ESSQS 认证和非 ESSQS 认证外科医生的长期疗效。
倾向评分匹配后,每组各纳入 315 对患者。非 ESSQS 组和 ESSQS 组的 3 年无复发生存率分别为 84.4%和 81.7%。差异为 2.7%(95%置信区间:-3.20%~8.44%,P<0.001),非 ESSQS 组的非劣效性检验结果具有统计学意义,因为下 95%置信限大于预设的-10%的差值。无复发生存的主要终点达成。两组 5 年无复发生存率(非 ESSQS 组:78.5%vs. ESSQS 组:77.4%,P=0.627)和 5 年总生存率(非 ESSQS 组:80.9%vs. ESSQS 组:79.3%,P=0.475)差异均无统计学意义。根据病理分期 I、II 和 III 期疾病的存在情况对肿瘤学结局进行分层,两组间也无显著差异。
在高容量中心,非 ESSQS 认证外科医生在有经验的外科医生指导下行 LG 可获得与 ESSQS 认证外科医生相当的肿瘤学结局。