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）。

Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial).

机构信息

Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.

Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.

出版信息

Br J Surg. 2021 Sep 27;108(9):1043-1049. doi: 10.1093/bjs/znab295.

DOI:10.1093/bjs/znab295

PMID:34487147

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).

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）的安全性和功能获益仍存在争议。本研究评估了一项比较胃癌 LPPG 与 LDG 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的、开放性标签、平行分组、优效性、多中心 RCT，在韩国进行。将至少距幽门 5cm 以上位于胃中三分之一处、cT1N0M0 期癌症的患者随机分为 LPPG 组或 LDG 组。参与者、护理人员和评估结果的人员对分组不知情。主要结局为 30 天术后发病率和 90 天死亡率。

结果

2015 年 7 月至 2017 年 7 月，来自 9 家机构的 256 名患者被随机分配（LPPG 组 129 例，LDG 组 127 例），对 253 名患者的结果进行了分析。LPPG 组和 LDG 组术后 30 天内分别有 19.3%和 15.5%的患者发生术后并发症（P=0.419）。LPPG 组和 LDG 组分别有 9 例（7.2%）和 2 例（1.5%）患者发生术后幽门狭窄（P=0.026）。多变量分析显示，较高的 BMI 是术后并发症的危险因素（比值比 1.17，95%置信区间 1.04 至 1.32；P=0.011）。两组患者在 90 天时均无死亡。