我们进行了一项随机前瞻性试验（KLASS-07 试验）来比较腹腔镜辅助远端胃切除术 (LADG) 和完全腹腔镜远端胃切除术 (TLDG) 治疗胃癌的情况。在这份中期报告中，我们描述了发病率和死亡率方面的短期结果。样本量为 442 名参与者。在进行中期分析时，共有 314 名患者入组并随机分组。排除未接受计划手术的患者后，我们分别对 LADG 组和 TLDG 组的 151 名患者和 145 名患者进行了修改后的符合方案分析。LADG 组和 TLDG 组的基线特征（包括合并症状态）没有差异。 LADG 组的失血量稍高，但未达到统计学显着性（76.76±72.63 vs. 62.91±65.68 mL；P=0.087）。两组之间所需的输血量以及手术或重建时间均没有差异。 LADG组的小型剖腹手术切口明显长于TLDG组取出标本所需的延长脐切口（4.79±0.82 vs. 3.89±0.83 cm；P<0.001）。术后 30 天内固体食物摄入时间、住院时间、疼痛评分或并发症方面没有组间差异。两组均未观察到死亡率。LADG 组和 TLDG 组之间的短期发病率和死亡率没有差异。 KLASS-07 试验目前正在进行中。ClinicalTrials.gov 标识符：NCT03393182。版权所有 © 2024。韩国胃癌协会。

We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality.The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively.The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group.Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway.ClinicalTrials.gov Identifier: NCT03393182.Copyright © 2024. Korean Gastric Cancer Association.