The First Department of Surgery, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.
J Hepatobiliary Pancreat Sci. 2012 May;19(3):230-41. doi: 10.1007/s00534-011-0466-6.
The value of pancreatoduodenectomy (PD) with extended lymphadenectomy for pancreatic cancer has been evaluated by many retrospective studies and 3 randomized controlled trials (RCT). However, the protocols used and the results found in the 3 RCTs were diverse. Therefore, a multicenter RCT was proposed in 1998 to evaluate the primary end point of long-term survival and the secondary end points of morbidity, mortality and quality of life of patients undergoing standard versus extended lymphadenectomy in radical PD for pancreatic cancer.
From March 2000 to May 2003, 112 patients with potentially curable pancreatic head cancer were enrolled and intraoperatively randomized to a standard or extended lymphadenectomy group. No resected patients received any adjuvant treatments.
A hundred and one eligible patients were analyzed. Demographic and histopathological characteristics of the two groups were similar. The mean operating time, intraoperative blood loss and number of retrieved lymph nodes were greater in the extended group, but the other operative results were comparable.
Although this multicenter RCT was conducted in a strict setting, extended lymphadenectomy in radical PD did not benefit long-term survival in patients with resectable pancreatic head cancer and led to levels of morbidity, mortality and quality of life comparable to those found after standard lymphadenectomy.
许多回顾性研究和 3 项随机对照试验（RCT）已经评估了胰十二指肠切除术（PD）联合扩大淋巴结清扫术治疗胰腺癌的价值。然而，这 3 项 RCT 使用的方案和得出的结果存在差异。因此，1998 年提出了一项多中心 RCT，以评估根治性 PD 治疗胰腺头癌时标准淋巴结清扫术与扩大淋巴结清扫术相比的主要终点（长期生存）和次要终点（发病率、死亡率和生活质量）。
从 2000 年 3 月至 2003 年 5 月，纳入了 112 例潜在可治愈的胰腺头癌患者，并在术中随机分为标准淋巴结清扫术组或扩大淋巴结清扫术组。未行切除的患者未接受任何辅助治疗。
101 例符合条件的患者被纳入分析。两组患者的人口统计学和组织病理学特征相似。扩大淋巴结清扫组的手术时间、术中出血量和淋巴结检出数较大，但其他手术结果相当。
尽管这项多中心 RCT 是在严格的条件下进行的，但根治性 PD 中的扩大淋巴结清扫术并不能使可切除的胰腺头癌患者的长期生存获益，且发病率、死亡率和生活质量与标准淋巴结清扫术相当。
