背景:腹腔镜辅助胃切除术(LG)由于其最小的侵入性而迅速普及。以前的研究发现,与二维(2D)-LG相比,三维(3D)-LG显示出更好的短期结果。然而,局部可切除胃癌(GC)患者的长期肿瘤结局仍存在争议.
方法:在这种非劣效性中,开放标签,随机临床试验,2015年1月至2016年4月,共有438名符合条件的GC参与者以1:1的比例随机分配给3D-LG或2D-LG.主要终点是运行时间,而次要终点包括5年总生存期(OS),无病生存率(DFS),和复发模式。
结果:来自401名参与者的数据被纳入符合方案分析,3D组中有204例患者,2D组中有197例患者。3D和2D组的5年OS和DFS率相当(5年OS:70.6%与71.1%,对数秩P=0.743;5年DFS:68.1%与69.0%,对数秩P=0.712)。3D组和2D组的5年复发率无显著差异(28.9%vs.28.9%,P=0.958)或复发时间(平均时间,22.6vs.20.5个月,P=0.412)。根据胃切除术的类型进一步分层分析,术后病理分期,术前BMI显示5年OS,DFS,3D组各亚组的复发率与2D组相似(均P>0.05)。
结论:对于局部可切除的GC患者,由经验丰富的外科医生在大量专业机构中执行的3D-LG可以实现与2D-LG相媲美的长期肿瘤学结果。
背景:NCT02327481(http://clinicaltrials.gov)。
Laparoscopy-assisted gastrectomy (LG) is rapidly gaining popularity owing to its minimal invasiveness. Previous studies have found that compared with two-dimensional (2D)-LG, three-dimensional (3D)-LG showed better short-term outcomes. However, the long-term oncological outcomes in patients with locally resectable gastric cancer (GC) remain controversial.
In this noninferiority, open-label, randomized clinical
trial, a total of 438 eligible GC participants were randomly assigned in a 1:1 ratio to either 3D-LG or 2D-LG from January 2015 to April 2016. The primary endpoint was operating time, while the secondary endpoints included 5-year overall survival (OS), disease-free survival (DFS), and recurrence pattern.
Data from 401 participants were included in the per-protocol analysis, with 204 patients in the 3D group and 197 patients in the 2D group. The 5-year OS and DFS rates were comparable between the 3D and 2D groups (5-year OS: 70.6% vs. 71.1%, Log-rank P = 0.743; 5-year DFS: 68.1% vs. 69.0%, log-rank P = 0.712). No significant differences were observed between the 3D and 2D groups in the 5-year recurrence rate (28.9% vs. 28.9%, P = 0.958) or recurrence time (mean time, 22.6 vs. 20.5 months, P = 0.412). Further stratified analysis based on the type of gastrectomy, postoperative pathological staging, and preoperative BMI showed that the 5-year OS, DFS, and recurrence rates of the 3D group in each subgroup were similar to those of the 2D group (all P > 0.05).
For patients with locally resectable GC, 3D-LG performed by experienced surgeons in high-volume professional institutions can achieve long-term oncological outcomes comparable to those of 2D-LG.
NCT02327481 ( http://clinicaltrials.gov ).