Abstract Background There remain concerns about the safety and functional benefit of laparoscopic pylorus-preserving gastrectomy (LPPG) compared with laparoscopic distal gastrectomy (LDG). This study evaluated short-term outcomes of a randomized clinical trial (RCT) comparing LPPG with LDG for gastric cancer. Methods The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS)-04 trial was an investigator-initiated, open-label, parallel-assigned, superiority, multicentre RCT in Korea. Patients with cT1N0M0 cancer located in the middle third of the stomach at least 5 cm from the pylorus were randomized to undergo LPPG or LDG. Participants, care givers and those assessing the outcomes were not blinded to group assignment. Outcomes were 30-day postoperative morbidity rate and death at 90 days. Results Some 256 patients from nine institutions were randomized (LPPG 129 patients, LDG 127 patients) between July 2015 and July 2017 and outcomes for 253 patients were analysed. Postoperative complications within 30 days were seen in 19.3 and 15.5 per cent in the LPPG and LDG groups respectively (P = 0·419). Postoperative pyloric stenosis was observed in nine (7.2 per cent) and two (1·5 per cent) patients in the LPPG and LDG groups (P = 0·026) respectively. In multivariable analysis higher BMI was a risk factor for postoperative complications (odds ratio 1·17, 95 per cent c.i. 1·04 to 1·32; P = 0·011). Death at 90 days was zero in both groups. Conclusion Postoperative complications and mortality was comparable in patients undergoing LPPG and LDG. Registration number: NCT02595086 (http://www.clinicaltrials.gov).

中文翻译：

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比较腹腔镜保留幽门胃切除术与腹腔镜远端胃切除术治疗胃癌的多中心随机临床试验的短期结果（KLASS-04 试验）

摘要 背景与腹腔镜远端胃切除术（LDG）相比，腹腔镜保留幽门胃切除术（LPPG）的安全性和功能益处仍然存在担忧。本研究评估了一项比较 LPPG 与 LDG 治疗胃癌的随机临床试验 (RCT) 的短期结果。 方法韩国腹腔镜胃肠外科研究 (KLASS)-04 试验是一项由研究者发起、开放标签、平行分配、优越性、多中心随机对照试验。位于胃中三分之一距幽门至少 5 厘米的 cT1N0M0 癌症患者被随机分配接受 LPPG 或 LDG。参与者、护理人员和评估结果的人员并未对分组分配视而不见。结果是术后 30 天的发病率和 90 天的死亡率。 结果2015 年 7 月至 2017 年 7 月期间，来自 9 个机构的约 256 名患者被随机分组​​（LPPG 129 名患者，LDG 127 名患者），并对 253 名患者的结果进行了分析。LPPG 组和 LDG 组术后 30 天内的并发症发生率分别为 19.3% 和 15.5% (P = 0·419)。LPPG 组和 LDG 组分别有 9 例 (7.2%) 和 2 例 (1·5%) 患者观察到术后幽门狭窄 (P = 0·026)。在多变量分析中，较高的 BMI 是术后并发症的危险因素（比值比 1·17，95% CI 1·04 至 1·32；P = 0·011）。两组的 90 天死亡率均为零。 结论接受 LPPG 和 LDG 的患者术后并发症和死亡率相当。注册号：NCT02595086 (http://www.clinicaltrials.gov)。