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一项比较单纯切除法氏囊和大网膜切除术治疗可切除胃癌的随机临床试验的五年随访(JCOG1001)。

Five-year follow-up of a randomized clinical trial comparing bursectomy and omentectomy alone for resectable gastric cancer (JCOG1001).

作者信息

Kurokawa Yukinori, Doki Yuichiro, Mizusawa Junki, Yoshikawa Takaki, Yamada Takanobu, Kimura Yutaka, Takiguchi Shuji, Nishida Yasunori, Fukushima Norimasa, Cho Haruhiko, Kaji Masahide, Hirao Motohiro, Sasako Mitsuru, Terashima Masanori

机构信息

Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.

Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.

出版信息

Br J Surg. 2022 Dec 13;110(1):50-56. doi: 10.1093/bjs/znac373.

DOI:10.1093/bjs/znac373
PMID:36369984
Abstract

BACKGROUND

Bursectomy, the total resection of the bursa omentalis, is a standard procedure in gastrectomy for resectable gastric cancer. A phase III trial (JCOG1001) comparing bursectomy and omentectomy alone was terminated early at the interim analysis. The final results of the updated analysis after a minimum follow-up of 5 years are reported here.

METHODS

Patients with histologically proven adenocarcinoma of the stomach (cT3-T4a) were randomized (1 : 1) during surgery to bursectomy or omentectomy-alone groups and then underwent D2 gastrectomy. The primary endpoint was overall survival, analysed on an intention-to-treat basis.

RESULTS

A total of 1204 patients (602 bursectomy and 602 omentectomy alone) were enrolled between June 2010 and March 2015. The bursectomy group had a significantly higher incidence of Clavien-Dindo grade III-IV intra-abdominal abscess than the omentectomy-alone group (5.5 versus 2.5 per cent respectively; P = 0.008). The updated 5-year overall survival rates were 74.9 (95 per cent c.i. 71.2 to 78.2) per cent in the bursectomy group and 76.5 (72.8 to 79.7) per cent in the omentectomy-alone group; the adjusted HR for death in the bursectomy group was 1.03 (95 per cent c.i. 0.83 to 1.27) (1-sided P = 0.598). Bursectomy did not decrease peritoneal recurrence (12.1 versus 12.3 per cent respectively; P = 1.000). In a multivariable analysis, old age (above 65 years), tumour located in the lower third or posterior wall of the stomach, macroscopic type 3/5, total gastrectomy, and cT4a were independent predictors of poor overall survival, but omentectomy alone was not.

CONCLUSION

In D2 gastrectomy, bursectomy is not recommended as a standard procedure for cT3-T4a gastric cancer. Registration number: UMIN000003688 (https://www.umin.ac.jp/ctr/).

摘要

背景

网膜囊切除术,即网膜囊的完全切除,是可切除胃癌胃切除术的标准术式。一项比较网膜囊切除术和单纯大网膜切除术的III期试验(JCOG1001)在中期分析时提前终止。本文报告了至少随访5年后更新分析的最终结果。

方法

组织学确诊为胃腺癌(cT3-T4a)的患者在手术期间被随机(1:1)分为网膜囊切除术组或单纯大网膜切除术组,然后接受D2胃切除术。主要终点为总生存期,基于意向性分析进行分析。

结果

2010年6月至2015年3月共纳入1204例患者(602例接受网膜囊切除术,602例接受单纯大网膜切除术)。网膜囊切除术组Clavien-Dindo III-IV级腹腔脓肿的发生率显著高于单纯大网膜切除术组(分别为5.5%和2.5%;P = 0.008)。更新后的5年总生存率在网膜囊切除术组为74.9%(95%置信区间71.2%至78.2%),在单纯大网膜切除术组为76.5%(72.8%至79.7%);网膜囊切除术组死亡的校正风险比为1.03(95%置信区间0.83至1.27)(单侧P = 0.598)。网膜囊切除术并未降低腹膜复发率(分别为12.1%和12.3%;P = 1.000)。在多变量分析中,老年(65岁以上)、肿瘤位于胃下三分之一或后壁、大体类型3/5、全胃切除术和cT4a是总生存期较差的独立预测因素,但单纯大网膜切除术不是。

结论

在D2胃切除术中,不推荐将网膜囊切除术作为cT3-T4a胃癌的标准术式。注册号:UMIN000003688(https://www.umin.ac.jp/ctr/)。

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