Journal of gastric cancer · 2025
Safety and Efficacy of Reduced-Port Versus Conventional Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Multicenter, Randomized, Non-inferiority Trial (KLASS-12).
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеEquivalence TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kim Hyoung-Il, Seo Hoseok, Hur Hoon, Lee Chang Min, Ahn Sang-Hoon, Park Dong Jin, Suh Yun-Suhk, Jeong Oh, Son Sang-Yong, Jung Mi Ran, Park Young Suk, Kim Dong-Wook, Song Jeong Ho, Lee Yoontaek, Park Ji-Ho, Park Shin-Hoo, Lee Sejin, Kong Seong-Ho, Hwang Sun-Hwi, Kim Jong Won, Lee Han Hong
Аннотация
PURPOSE: This trial (KLASS-12) compares the efficacy and safety of reduced-port laparoscopic gastrectomy (RPLG) versus conventional 5-port laparoscopic gastrectomy (CPLG) for early gastric cancer (EGC).
MATERIALS AND METHODS: This multicenter, open-label, randomized controlled trial enrolled patients diagnosed with gastric adenocarcinoma (T1N0M0) at 15 university hospitals in Korea. Participants underwent RPLG or CPLG with at least D1+ lymph node dissection. The primary aim of this study was to verify the non-inferiority of RPLG to CPLG in terms of postoperative 30-day complications.
RESULTS: From May 2022 to October 2023, 348 patients were randomly assigned to the RPLG and CPLG groups, with 174 patients in each group. After applying the exclusion criteria, 164 and 166 patients from the RPLG and CPLG groups, respectively, were analyzed. Complication rates were 10.4% and 9.2% for the RPLG and CPLG groups, in the intention-to-treat (ITT) population, and 10.4% vs. 7.2% in the per-protocol (PP) population. The risk difference was 0.012 (95% confidence interval [CI], -0.051 to 0.075) in the ITT population and 0.031 (95% CI, -0.030 to 0.093) in the PP population. These findings verified the non-inferiority of RPLG to CPLG, with a 10% margin. Additionally, the pain score on postoperative day 5 was significantly lower in the RPLG group (1.6% vs. 1.8%; P=0.028). The 2 groups showed no significant differences in the lymph node yield, conversion rate, or length of hospital stay. RPLG was not an independent risk factor for complications.
CONCLUSIONS: RPLG is a feasible and safe alternative for patients with EGC, and its short-term outcomes are not inferior to those of CPLG.
TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0006935.
MATERIALS AND METHODS: This multicenter, open-label, randomized controlled trial enrolled patients diagnosed with gastric adenocarcinoma (T1N0M0) at 15 university hospitals in Korea. Participants underwent RPLG or CPLG with at least D1+ lymph node dissection. The primary aim of this study was to verify the non-inferiority of RPLG to CPLG in terms of postoperative 30-day complications.
RESULTS: From May 2022 to October 2023, 348 patients were randomly assigned to the RPLG and CPLG groups, with 174 patients in each group. After applying the exclusion criteria, 164 and 166 patients from the RPLG and CPLG groups, respectively, were analyzed. Complication rates were 10.4% and 9.2% for the RPLG and CPLG groups, in the intention-to-treat (ITT) population, and 10.4% vs. 7.2% in the per-protocol (PP) population. The risk difference was 0.012 (95% confidence interval [CI], -0.051 to 0.075) in the ITT population and 0.031 (95% CI, -0.030 to 0.093) in the PP population. These findings verified the non-inferiority of RPLG to CPLG, with a 10% margin. Additionally, the pain score on postoperative day 5 was significantly lower in the RPLG group (1.6% vs. 1.8%; P=0.028). The 2 groups showed no significant differences in the lymph node yield, conversion rate, or length of hospital stay. RPLG was not an independent risk factor for complications.
CONCLUSIONS: RPLG is a feasible and safe alternative for patients with EGC, and its short-term outcomes are not inferior to those of CPLG.
TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0006935.