Standard versus extended lymphadenectomy in radical pancreatoduodenectomy for ductal adenocarcinoma of the head of the pancreas: long-term results of a Japanese multicenter randomized controlled trial.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
The First Department of Surgery, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan. ynimura@aichi-cc.jp
Yuji
Y
Nimura
Masato
M
Nagino
Sonshin
S
Takao
Tadahiro
T
Takada
Koji
K
Miyazaki
Yoshifumi
Y
Kawarada
Shuichi
S
Miyagawa
Akihiro
A
Yamaguchi
Shuichi
S
Ishiyama
Yutaka
Y
Takeda
Kourou
K
Sakoda
Taira
T
Kinoshita
Kenzo
K
Yasui
Hiroshi
H
Shimada
Hiroyuki
H
Katoh
D000230:Adenocarcinoma / Q000401:mortality / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008197:Lymph Node Excision / Q000379:methods*; D008198:Lymph Nodes / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012187:Retroperitoneal Space; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome