{"title":"三维与二维腹腔镜胃切除术治疗胃癌的长期肿瘤治疗效果：随机临床试验。","authors":"Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan, Zhi-Yu Liu, Guang-Tan Lin, Dong Wu, Yi-Ming Jiang, Jia-Bin Wang, Jian-Xian Lin, Qi-Yue Chen, Ju-Li Lin, Jian-Wei Xie, Ping Li, Jun Lu, Chang-Ming Huang, Chao-Hui Zheng","doi":"10.1007/s10120-024-01470-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration number: </strong>NCT02327481 ( http://clinicaltrials.gov ).</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":null,"pages":null},"PeriodicalIF":6.0000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial.\",\"authors\":\"Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan, Zhi-Yu Liu, Guang-Tan Lin, Dong Wu, Yi-Ming Jiang, Jia-Bin Wang, Jian-Xian Lin, Qi-Yue Chen, Ju-Li Lin, Jian-Wei Xie, Ping Li, Jun Lu, Chang-Ming Huang, Chao-Hui Zheng\",\"doi\":\"10.1007/s10120-024-01470-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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). 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引用次数: 0
摘要
背景：腹腔镜辅助胃切除术（LG）因其微创性而迅速普及。以往的研究发现，与二维（2D）胃切除术相比，三维（3D）胃切除术的短期疗效更好。然而，局部可切除胃癌（GC）患者的长期肿瘤治疗效果仍存在争议：在这项非劣效性、开放标签、随机临床试验中，从2015年1月到2016年4月，共有438名符合条件的GC参与者按1:1的比例被随机分配到3D-LG或2D-LG中。主要终点是手术时间，次要终点包括5年总生存期（OS）、无病生存期（DFS）和复发模式：来自401名参与者的数据被纳入按方案分析，其中三维组204名患者，二维组197名患者。三维组和二维组的 5 年 OS 和 DFS 率相当（5 年 OS：70.6% vs. 71.1%，Log-rank P = 0.743；5 年 DFS：68.1% vs. 69.0%，Log-rank P = 0.712）。在5年复发率（28.9% vs. 28.9%，P = 0.958）或复发时间（平均时间22.6个月 vs. 20.5个月，P = 0.412）方面，3D组和2D组之间未观察到明显差异。根据胃切除术类型、术后病理分期和术前体重指数进行的进一步分层分析表明，各亚组中三维组的5年OS、DFS和复发率与二维组相似（P均>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样本量的专业机构进行 3D-LG 治疗，可获得与 2D-LG 相媲美的长期肿瘤治疗效果：NCT02327481 ( http://clinicaltrials.gov ).
Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial.
Background: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
期刊介绍：
Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide.
The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics.
Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field.
With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.
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