胃癌患者行根治性胃切除术时行 D2 淋巴结清扫术与 D2 淋巴结清扫术加全胃系膜切除术的随机临床试验（DCGC01 研究）。

Randomized clinical trial on D2 lymphadenectomy versus D2 lymphadenectomy plus complete mesogastric excision in patients undergoing gastrectomy for cancer (DCGC01 study).

机构信息

Department of Gastrointestinal Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.

Department of Breast Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.

出版信息

Br J Surg. 2024 May 3;111(5). doi: 10.1093/bjs/znae106.

DOI:10.1093/bjs/znae106

PMID:38713611

Abstract

BACKGROUND

It is unknown whether D2 lymphadenectomy + complete mesogastric excision for gastric cancer improves survival compared with just D2 lymphadenectomy.

METHODS

Between September 2014 and June 2018, patients with advanced gastric cancer were randomly assigned (1 : 1) to laparoscopic D2 lymphadenectomy or D2 lymphadenectomy + complete mesogastric excision gastrectomy. The modified intention-to-treat population was defined as patients who had pathologically confirmed gastric adenocarcinoma (pT1 N1-3 M0 and pT2-4 N0-3 M0). The primary endpoint was 3-year disease-free survival. Secondary endpoints were the recurrence pattern and overall survival.

RESULTS

The median follow-up of patients in the D2 lymphadenectomy group (169 patients) and patients in the D2 lymphadenectomy +complete mesogastric excision group (169 patients) was 55 (interquartile range 37-60) months and 51 (interquartile range 40-60) months respectively. Recurrence occurred in 50 patients in the D2 lymphadenectomy group (29.6%) versus 33 patients in the D2 lymphadenectomy + complete mesogastric excision group (19.5%) (P = 0.032). The 3-year disease-free survival was 75.5% (95% c.i. 68.3% to 81.3%) in the D2 lymphadenectomy group versus 85.0% (95% c.i. 78.7% to 89.6%) in the D2 lymphadenectomy + complete mesogastric excision group (log rank P = 0.042). The HR for recurrence in the D2 lymphadenectomy + complete mesogastric excision group versus the D2 lymphadenectomy group was 0.64 (95% c.i. 0.41 to 0.99) by Cox regression (P = 0.045). The 3-year overall survival rate was 77.5% (95% c.i. 70.4% to 83.1%) in the D2 lymphadenectomy group versus 85.8% (95% c.i. 79.6% to 90.2%) in the D2 lymphadenectomy + complete mesogastric excision group (log rank P = 0.058). The HR for death in the D2 lymphadenectomy + complete mesogastric excision group versus the D2 lymphadenectomy group was 0.64 (95% c.i. 0.41 to 1.02) (P = 0.058).

CONCLUSION

Compared with conventional D2 dissection, D2 lymphadenectomy + complete mesogastric excision is associated with better disease-free survival, but there is no statistically significant difference in overall survival.

REGISTRATION NUMBER

NCT01978444 (http://www.clinicaltrials.gov).

摘要

背景

目前尚不清楚胃癌的 D2 淋巴结清扫术+完整中胃切除术是否比单纯 D2 淋巴结清扫术更能提高生存率。

方法

2014 年 9 月至 2018 年 6 月，将晚期胃癌患者随机分为腹腔镜 D2 淋巴结清扫术组或 D2 淋巴结清扫术+完整中胃切除术组（1：1）。经修正的意向治疗人群定义为经病理证实患有胃腺癌的患者（pT1 N1-3 M0 和 pT2-4 N0-3 M0）。主要终点为 3 年无病生存率。次要终点为复发模式和总生存率。

结果

D2 淋巴结清扫术组（169 例）和 D2 淋巴结清扫术+完整中胃切除术组（169 例）患者的中位随访时间分别为 55（四分位距 37-60）个月和 51（四分位距 40-60）个月。D2 淋巴结清扫术组（29.6%）和 D2 淋巴结清扫术+完整中胃切除术组（19.5%）（P=0.032）患者中有 50 例（29.6%）发生复发。D2 淋巴结清扫术组的 3 年无病生存率为 75.5%（95%置信区间 68.3%至 81.3%），D2 淋巴结清扫术+完整中胃切除术组为 85.0%（95%置信区间 78.7%至 89.6%）（对数秩检验 P=0.042）。Cox 回归分析显示，D2 淋巴结清扫术+完整中胃切除术组与 D2 淋巴结清扫术组相比，复发的 HR 为 0.64（95%置信区间 0.41 至 0.99）（P=0.045）。D2 淋巴结清扫术组的 3 年总生存率为 77.5%（95%置信区间 70.4%至 83.1%），D2 淋巴结清扫术+完整中胃切除术组为 85.8%（95%置信区间 79.6%至 90.2%）（对数秩检验 P=0.058）。D2 淋巴结清扫术+完整中胃切除术组与 D2 淋巴结清扫术组相比，死亡的 HR 为 0.64（95%置信区间 0.41 至 1.02）（P=0.058）。