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李国新教授发文JCO！探讨微创与开腹对进展期胃癌的安全性和有效性

2016年02月29日

编译：文茶

腹腔镜与开腹下远端胃癌D2根治术对进展期胃癌的安全性比较：一项随机对照临床试验

李国新南方医科大学南方医院普外科

Journal of clinical oncology February 22, 2016

胃癌每年影响着超过40万国人的健康，对于局部进展期胃癌患者，根治性手术仍然是标准治疗方案。根据日本胃癌规约，开腹行远端胃大部切除术+D2淋巴结清扫为目前治疗中下段进展期胃癌的标准术式。

尽管腹腔镜胃大部切除在早期胃癌中已广泛引用，但其在进展期胃癌中的治疗作用仍不明确。KLASS和JLSSG均在进行腹腔镜治疗进展期胃癌的多中心随机临床试验，探讨其在晚期胃癌中的作用。中国腹腔镜胃肠手术研究小组也在国内开展了腹腔镜远端胃切除+D2淋巴结清扫与开腹治疗的前瞻多中心随机对照研究。

研究目的：

腹腔镜远端胃切除术+D2淋巴结清扫术在治疗进展期胃癌中的安全性和有效性仍在研究和探讨之中。我们开展了一项随机对照试验，比较腹腔镜和传统开腹行远端胃切除+D2淋巴结清扫在进展期胃癌中的作用。

患者与方法：

2012年9月至2014年12月，共有1056名cT2-4aN0-3M0期胃癌患者入组。患者随机入组，腹腔镜远端胃大部切除+D2淋巴结清扫和开腹手术组患者各528人。全国14家研究机构，15个有经验的外科团队参与此研究项目。30天内术后发生并发症和死亡例数两组分别为腹腔镜组（519例）开腹组（520例），根据优化意向治疗原则，两组患者同质可比。术后并发症根据Claiven-Dindo分型分类。

结果：

D2淋巴结清扫术在腹腔镜组和开腹组开展率相当99.4% vs. 99.6%；P=0.845。术后并发症发生率腹腔镜组和开腹手术组分别为15.2%和12.9%，无显著差异（差异2.3%，95%CI，-1.9~6.6；P=0.285）两组患者术后死亡率为开腹组0.4%，腹腔镜组0%（差异0.4%，95%CI，-0.4~1.4；P=0.249）。两组患者并发症严重程度相似（P=0.314）。

结论：

经验丰富的外科团队可以安全的行腹腔镜远端胃切除术+D2淋巴结清扫来治疗进展期胃癌。

本研究确认部分患者进行腹腔镜远端胃切除+D2淋巴结清扫，利于患者术后快速康复，且术后出血量更少、下床更早、肠功能恢复更快以及更短的住院时间。至于腹腔镜手术与开腹手术治疗进展期胃癌的远期效果，其3年无病生存率将会在2017年得到总结。

Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial

Abstract

Purpose The safety and efficacy of radical laparoscopic distal gastrectomy (LG) with D2 lymphadenectomy for the treatment of advanced gastric cancer (AGC) remain controversial. We conducted a randomized controlled trial to compare laparoscopic and conventional open distal gastrectomy with D2 lymph node dissections for AGC.

Patients and Methods Between September 2012 and December 2014, 1,056 patients with clinical stage T2-4aN0-3M0 gastric cancer were eligible for inclusion. They were randomly assigned to either the LG with D2 lymphadenectomy group (n = 528) or the open gastrectomy (OG) with D2 lymphadenectomy group (n = 528). Fifteen experienced surgeons from 14 institutions in China participated in the study. The morbidity and mortality within 30 days after surgery between the LG (n = 519) and the OG (n = 520) groups were compared on the basis of the modified intention-to-treat principle. Postoperative complications were stratified according to the Clavien-Dindo classification.

Results The compliance rates of D2 lymphadenectomy were similar between the LG and OG groups (99.4% v 99.6%; P = .845). The postoperative morbidity was 15.2% in the LG group and 12.9% in OG group with no significant difference (difference, 2.3%; 95% CI, –1.9 to 6.6; P = .285). The mortality rate was 0.4% for the LG group and zero for the OG group (difference, 0.4%; 95% CI, –0.4 to 1.4; P = .249). The distribution of severity was similar between the two groups (P = .314).

Conclusion Experienced surgeons can safely perform LG with D2 lymphadenectomy for AGC.

（本文为【良医汇-肿瘤资讯】原创，欢迎转发，转载需经授权并注明出处）

原文链接：http://jco.ascopubs.org/content/early/2016/02/17/JCO.2015.63.7215.abstract