Nodal dissection for patients with gastric cancer: a randomised controlled trial
Nodal dissection for patients with gastric cancer: a randomised controlled trial
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DOI：
10.1016/s1470-2045(06)70623-4
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发表时间：
2006-04-01
期刊：
影响因子：
51.1
通讯作者：
Whang-Peng, J
中科院分区：
文献类型：
--
作者：
Wu, CW;Hsiung, CA;Whang-Peng, J
背景胃癌淋巴结清扫后的生存获益和发病率仍有争议。我们的目标是进行一项单机构随机试验，比较D1（即1级）淋巴结切除术与D3（即1、2和3级）胃癌清扫术在总生存期和无病生存期方面的差异。方法1993年10月7日至1999年8月12日对335例患者进行临床资料登记。221例患者符合条件，其中110例随机分配D1手术，1例随机分配D3手术，均有治疗目的。三名参与试验的外科医生在试验开始前至少进行了25次独立的D3解剖，每一次手术都经过病理分析的验证。主要终点是5年总生存率和5年无病生存率。我们还分析了复发的风险。主要分析以意向治疗为主。该试验已在美国国立卫生研究院网站http://www.clinicaltrials.gov/ct/show/NCT00260884.Findings注册，110名（50%）幸存者的中位随访时间为94.5个月（范围62.9-135.1）。接受D3手术的患者总体5年生存率显著高于接受D1手术的患者（59.5% [95% CI 50.3-68.7] vs 53.6%[44.2-63.0]；组间差异5.9% [-7.3 - 19.1],log-rank p = 0.04）。215例R0切除患者（即无显微残留病变证据）5年复发率D1为50.6% [41.1-60.2]，D3为40.3%[30.9-49.7]（组间差异10.3% [-3.2 ~ 23,7],log-rank p = 0.197）。解释：与D1相比，由训练有素、经验丰富的外科医生进行D3淋巴结清扫可提高胃癌患者的生存率。
Background The survival benefit and morbidity after nodal dissection for gastric cancer remains controversial. We aimed to do a single-institution randomised trial to compare D1 (ie, level 1) lymphadenectomy with that of D3 (ie, levels 1, 2, and 3) dissection for gastric cancer in terms of overall survival and disease-free survival.Methods From Oct 7, 1993, to Aug 12, 1999, 335 patients were registered. 221 patients were eligible, 110 of whom were randomly assigned D1 surgery and ill of whom were randomly assigned D3 surgery, both with curative intent. Three participating surgeons had done at least 25 independent D3 dissections before the start of the trial, and every procedure was verified by pathological analyses. The primary endpoints were 5-year overall survival and 5-year disease-free survival. We also analysed risk of recurrence. Main analyses were done by intention to treat. This trial is registered at the US National Institute of Health website http://www.clinicaltrials.gov/ct/show/NCT00260884.Findings Median follow-up for the 110 (50%) survivors was 94.5 months (range 62.9-135.1). Overall 5-year survival was significantly higher in patients assigned D3 surgery than in those assigned D1 surgery (59.5% [95% CI 50.3-68.7] vs 53.6% [44.2-63.0]; difference between groups 5.9% [-7.3 to 19.1], log-rank p = 0.04). 215 patients who had R0 resection (ie, no microscopic evidence of residual disease) had recurrence at 5 years of 50.6% [41.1-60.2] for D1 surgery and 40.3% [30.9-49.7] for D3 surgery (difference between groups 10.3% [-3.2 to 23,7], log-rank p = 0.197).Interpretation D3 nodal dissection, compared with that of D1, offers a survival benefit for patients with gastric cancer when done by well trained, experienced surgeons.