Department of Surgery, Korea University College of Medicine.
Division of Foregut Surgery, Korea University Anam Hospital.
Int J Surg. 2024 Aug 1;110(8):4810-4820. doi: 10.1097/JS9.0000000000001543.
Strong evidence is lacking as no confirmatory randomized controlled trials (RCTs) have compared the efficacy of totally laparoscopic distal gastrectomy (TLDG) with laparoscopy-assisted distal gastrectomy (LADG). The authors performed an RCT to confirm if TLDG is different from LADG.
The KLASS-07 trial is a multi-centre, open-label, parallel-group, phase III, RCT of 442 patients with clinical stage I gastric cancer. Patients were enroled from 21 cancer care centres in South Korea between January 2018 and September 2020 and randomized to undergo TLDG or LADG using blocked randomization with a 1:1 allocation ratio, stratified by the participating investigators. Patients were treated through R0 resections by TLDG or LADG as the full analysis set of the KLASS-07 trial. The primary endpoint was morbidity within postoperative day 30, and the secondary endpoint was quality of life (QoL) for 1 year. This trial is registered at ClinicalTrials.gov (NCT03393182).
Four hundred forty-two patients were randomized (222 to TLDG, 220 to LADG), and 422 patients were included in the pure analysis (213 and 209, respectively). The overall complication rate did not differ between the two groups (TLDG vs. LADG: 12.2% vs. 17.2%). However, TLDG provided less postoperative ileus and pulmonary complications than LADG (0.9% vs. 5.7%, P= 0.006; and 0.5% vs. 4.3%, P= 0.035, respectively). The QoL was better after TLDG than after LADG regarding emotional functioning at 6 months, pain at 3 months, anxiety at 3 and 6 months, and body image at 3 and 6 months (all P< 0.05). However, these QoL differences were resolved at 1 year.
The KLASS-07 trial confirmed that TLDG is not different from LADG in terms of postoperative complications but has the advantages to reduce ileus and pulmonary complications. TLDG can be a good option to offer better QoL in terms of pain, body image, emotion, and anxiety at 3-6 months.
由于没有确证性随机对照试验（RCT）比较完全腹腔镜远端胃切除术（TLDG）与腹腔镜辅助远端胃切除术（LADG）的疗效，因此缺乏强有力的证据。作者进行了一项 RCT 以确认 TLDG 是否与 LADG 不同。
KLASS-07 试验是一项多中心、开放标签、平行组、III 期 RCT，纳入了 442 例临床 I 期胃癌患者。患者于 2018 年 1 月至 2020 年 9 月期间在韩国的 21 个癌症治疗中心入组，并通过 1:1 分配比例、按参与研究者分层的区组随机化，分为 TLDG 组或 LADG 组。TLDG 或 LADG 行 R0 切除，患者作为 KLASS-07 试验的全分析集接受治疗。主要终点为术后 30 天内的发病率，次要终点为 1 年时的生活质量（QoL）。本试验在 ClinicalTrials.gov 注册（NCT03393182）。
442 例患者随机分组（TLDG 组 222 例，LADG 组 220 例），422 例患者纳入纯粹分析（TLDG 组和 LADG 组分别为 213 例和 209 例）。两组总体并发症发生率无差异（TLDG 组与 LADG 组：12.2%比 17.2%）。然而，TLDG 组术后肠梗阻和肺部并发症少于 LADG 组（0.9%比 5.7%，P=0.006；0.5%比 4.3%，P=0.035）。TLDG 组术后 6 个月时情绪功能、3 个月时疼痛、3 个月和 6 个月时焦虑、3 个月和 6 个月时身体形象的 QoL 均优于 LADG 组（均 P<0.05）。然而，这些 QoL 差异在 1 年后得到解决。
KLASS-07 试验证实，TLDG 在术后并发症方面与 LADG 无差异，但具有减少肠梗阻和肺部并发症的优势。TLDG 可作为一种较好的选择，在 3-6 个月时提供更好的疼痛、身体形象、情绪和焦虑方面的 QoL。
