Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea.
JAMA Oncol. 2019 Apr 1;5(4):506-513. doi: 10.1001/jamaoncol.2018.6727.
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.
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.
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.
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).
Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was prespecified as -5% (corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group.
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.
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.
ClinicalTrials.gov identifier: NCT00452751.
腹腔镜远端胃切除术因其术后早期结果更好而逐渐普及，用于治疗胃癌。然而，据我们所知，尚无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性远端胃切除术。
检查接受腹腔镜远端胃切除术的 I 期胃癌患者的长期生存情况是否不劣于接受开放性远端胃切除术的患者。
韩国腹腔镜胃肠外科学会（KLASS）组由 13 家机构的 15 名外科医生组成，于 2006 年 1 月 5 日至 2010 年 8 月 23 日进行了一项具有里程碑意义的 III 期、多中心、开放性、非劣效性、前瞻性随机临床试验（KLASS-01），纳入了术前临床 I 期胃腺癌的组织学证实患者。在 2016 年 12 月确定了患者的生存和复发情况。
患者被随机（1:1）分配至腹腔镜远端胃切除术（n=705）或开放性远端胃切除术（n=711）。其中 85 例患者接受了与随机分组相反的手术方式（63 例接受开放手术组，22 例接受腹腔镜组）。
腹腔镜和开放性远端胃切除术组 5 年总生存率的差异。非劣效性边界预设为-5%（相应的危险比为 1.54），开放手术组假设 5 年后的生存率为 90%。
在纳入的 1416 例患者（平均[SD]年龄为 57.3[11.1]岁，940[66.4%]为男性）中，腹腔镜组的 5 年总生存率为 94.2%，开放手术组为 93.3%（对数秩检验 P=0.64）。意向治疗分析证实了腹腔镜方法与开放性方法相比具有非劣效性（差异为 0.9 个百分点；单侧 97.5%CI，-1.6 至无穷大）。两组的 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%，对数秩检验 P=0.91；差异为-0.03 个百分点；单侧 97.5%CI，-1.8 至无穷大）。按方案分析的结果与意向治疗结果一致，用于总体生存率和癌症特异性生存率。
KLASS-01 试验显示，接受腹腔镜和开放性远端胃切除术的患者的总体生存率和癌症特异性生存率相似。腹腔镜远端胃切除术是治疗 I 期胃癌的一种肿瘤学上安全的开放性手术替代方法。
ClinicalTrials.gov 标识符：NCT00452751。
