{"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":" ","pages":"598-610"},"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). 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\":\" \",\"pages\":\"598-610\"},\"PeriodicalIF\":6.0000,\"publicationDate\":\"2024-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gastric Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10120-024-01470-0\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/20 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastric Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10120-024-01470-0","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/20 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
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.
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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.