Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer The KLASS-01 Randomized Clinical Trial
Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer The KLASS-01 Randomized Clinical Trial
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DOI：
10.1001/jamaoncol.2018.6727
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发表时间：
2019-04-01
期刊：
影响因子：
28.4
通讯作者：
Yu, Wansik
中科院分区：
文献类型：
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作者：
Kim, Hyung-Ho;Han, Sang-Uk;Yu, Wansik
重要性腹腔镜远端胃切除术因其较好的早期术后结局而比开放式远端胃切除术更受欢迎。然而，据我们所知，还没有研究证明腹腔镜远端胃切除术在肿瘤学上是否等同于开放式远端胃切除术。目的研究接受腹腔镜远端胃切除术的I期胃癌患者的长期生存率是否不劣于接受开放式远端胃切除术的患者。包括来自13个研究所的15名外科医生，对2006年1月5日至2010年8月23日期间经组织学证实的术前临床I期胃腺癌患者进行了3期、多中心、开放标签、非劣效性、前瞻性随机临床试验（KLASS-01）。2016年12月确定患者的生存和复发状态。干预患者被随机分配（1：1）至腹腔镜远端胃切除术（n = 705）或开放性远端胃切除术（n = 711）。在这些患者中，85例接受了手术方法相反的一个，他们被随机分配（63随机开放手术组和22腹腔镜组）。主要结果和测量腹腔镜和开放远端胃切除术组之间的5年总生存率的差异。非劣效性界值预先规定为-5%（相应的风险比为1.54），假设开放手术组5年后的生存率为90%。（平均[SD]年龄，57.3 [11.1]岁; 940例[66.4%]男性），腹腔镜组5年总生存率为94.2%，开放手术组为93.3%（对数秩P = 0.64）。意向性治疗分析证实了腹腔镜方法与开放方法相比的非劣效性（差异，0.9个百分点;单侧97.5%CI，-1.6至无穷大）。两组之间的5年癌症特异性生存率相似（腹腔镜组为97.1%，开放手术组为97.2%，对数秩P = 0.91;差异为-0.03个百分点;单侧97.5%CI为-1.8至无穷大）。符合协议的分析结果是一致的意向治疗结果的整体和癌症特异性survivalrate.CONCLUSIONS和RELEVANCE的KLASS-01试验显示，类似的整体和癌症特异性生存率之间的患者接受腹腔镜和开放式远端胃切除术。腹腔镜远端胃切除术是I期胃癌开放手术的一种肿瘤安全替代方案。试验注册ClinicalTrials.gov标识符：NCT 00452751
IMPORTANCE Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes. However, to our knowledge, no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy.OBJECTIVE To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy.DESIGN The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group, which includes 15 surgeons from 13 institutes, conducted a phase 3, multicenter, open-label, noninferiority, prospective randomized clinical trial (KLASS-01) of patients with histologically proven, preoperative clinical stage I gastric adenocarcinoma from January 5, 2006, to August 23, 2010. Survival and recurrence status of the patients was determined in December 2016.INTERVENTIONS Patients were randomly assigned (1: 1) to laparoscopic distal gastrectomy (n = 705) or open distal gastrectomy (n = 711). Of these patients, 85 received a surgical approach opposite the one to which they were randomized (63 randomized to the open surgery group and 22 to the laparoscopic group).MAIN OUTCOMES AND MEASURES Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was pre-specified as -5%(corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group.RESULTS Among the 1416 patients (mean [SD] age, 57.3 [11.1] years; 940 [66.4%] male) included in the study, the 5-year overall survival rates were 94.2% in the laparoscopic group and 93.3% in the open surgery group (log-rank P = .64). Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach (difference, 0.9 percentage points; 1-sided 97.5% CI, -1.6 to infinity). The 5-year cancer-specific survival rates were similar between the 2 groups (97.1% in the laparoscopic group and 97.2% in the open surgery group, log-rank P = .91; difference, -0.03 percentage points; 1-sided 97.5% CI, -1.8 to infinity). Per-protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates.CONCLUSIONS AND RELEVANCE The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy. Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer.TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00452751