局部进展期胃癌腹腔镜手术方法的全国性验证：随机对照试验与真实世界实践结果的比较。

National validation of laparoscopic approach for locally advanced gastric cancer: Comparison of a randomized controlled trial and real-world practice results.

作者信息

Eom Bang Wool, Han Mira, Yoon Hong Man, Hyung Woo Jin, Yang Han-Kwang, Park Young-Kyu, Lee Hyuk-Joon, An Ji Yeong, Kim Wook, Kim Hyoung-Il, Kim Hyung-Ho, Ryu Seung Wan, Hur Hoon, Kim Min-Chan, Kong Seong-Ho, Cho Gyu Seok, Kim Jin-Jo, Park Do Joong, Kim Young-Woo, Kim Jong Won, Lee Joo-Ho, Han Sang-Uk, Ryu Keun Won, Of The Korean Gastric Cancer Association The Information Committee

机构信息

Center of Gastric Cancer, National Cancer Center, Goyang 10408, Republic of Korea.

Department of Medical Research Collaborating Center, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul 07061, Republic of Korea.

出版信息

Chin J Cancer Res. 2024 Dec 30;36(6):742-751. doi: 10.21147/j.issn.1000-9604.2024.06.11.

DOI:10.21147/j.issn.1000-9604.2024.06.11

PMID:39802891

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11724173/

Abstract

OBJECTIVE

The laparoscopic approach for locally advanced gastric cancer has recently been adopted based on the results of several randomized controlled trials (RCTs). However, findings from RCTs have not been examined at the national level. This study aimed to investigate the external validity of the Korean Laparoscopic Gastrointestinal Surgery Study-02 (KLASS-02) trial involving 13 tertiary hospitals, using data from the Korean Gastric Cancer Association (KGCA)-led nationwide survey involving 68 tertiary or general hospitals.

METHODS

Data on patients who underwent laparoscopic or open distal gastrectomy for pathological stage IB-IIIC gastric cancer under the same conditions were collected from the KLASS-02 trial and the KGCA nationwide survey datasets. Surgical outcomes were assessed for each dataset and multivariable analyses were performed to examine the effect of the laparoscopic approach on surgical outcomes.

RESULTS

The laparoscopic group had a lower overall complication rate than the open group in both KLASS-02 and KGCA datasets (16.1% . 23.5% for the KLASS-02 and 12.6% . 19.6% for the KGCA). Moreover, the laparoscopic group had fewer wound problems, and fewer grade II, IIIa, and IV complications than the open group in the KGCA data (0.8% . 3.4%, 5.8% . 10.4%, 2.3% . 3.7%, and 0.5% . 1.4%, respectively), which were not observed in the KLASS-02 data. Multivariable analyses revealed that the laparoscopic approach was not associated with overall complications, but reduced wound problems and more harvested lymph nodes in the KGCA survey data (adjusted odds ratios, 0.19 for wound problems, adjusted β coefficient 4.39 for number of harvested lymph nodes), which were not shown in the KLASS-02 data.

CONCLUSIONS

The safety and feasibility of the laparoscopic approach for locally advanced gastric cancer were validated at a national level. The laparoscopic approach for locally advanced gastric cancer can be implemented in the Republic of Korea.

摘要

目的

基于多项随机对照试验（RCT）的结果，腹腔镜手术治疗局部进展期胃癌的方法最近已被采用。然而，RCT的研究结果尚未在国家层面进行检验。本研究旨在利用韩国胃癌协会（KGCA）牵头的涉及68家三级或综合医院的全国性调查数据，调查涉及13家三级医院的韩国腹腔镜胃肠手术研究-02（KLASS-02）试验的外部有效性。

方法

从KLASS-02试验和KGCA全国性调查数据集中收集在相同条件下接受腹腔镜或开放远端胃癌切除术的病理分期为IB-IIIC期胃癌患者的数据。对每个数据集评估手术结果，并进行多变量分析以检验腹腔镜手术方法对手术结果的影响。

结果

在KLASS-02和KGCA数据集中，腹腔镜组的总体并发症发生率均低于开放组（KLASS-02中为16.1%对23.5%，KGCA中为12.6%对19.6%）。此外，在KGCA数据中，腹腔镜组的伤口问题更少，II级、IIIa级和IV级并发症也比开放组少（分别为0.8%对3.4%、5.8%对10.4%、2.3%对3.7%和0.5%对1.4%），而这些在KLASS-02数据中未观察到。多变量分析显示，腹腔镜手术方法与总体并发症无关，但在KGCA调查数据中减少了伤口问题并增加了获取的淋巴结数量（伤口问题的调整比值比为0.19，获取淋巴结数量的调整β系数为4.39），而这些在KLASS-02数据中未显示。