Standard D2 versus extended D2 (D2+) lymphadenectomy for gastric cancer: an interim safety analysis of a multicenter, randomized, clinical trial.
BACKGROUND
A multicenter, randomized, clinical trial was initiated to evaluate the possible benefits of extended D2 (D2+) lymphadenectomy after potentially curative resection of gastric cancer.


METHODS
Standard D2 lymphadenectomy was defined according to the Japanese Gastric Cancer Association classification. D2+ lymph node dissection additionally included the removal of para-aortic nodes.


RESULTS
Of 781 patients screened, 275 were randomized to standard D2 (n = 141) or extended D2+ (n = 134) lymphadenectomy. The overall morbidity rates were comparable in D2 (27.7%; 95% confidence interval [CI], 20.3-35.1) and D2+ (21.6%; 95% CI, 13.7-29.5) groups (P = .248). Pre-existing cardiac disease, splenectomy, and excessive blood loss were identified as risk factors for overall and nonsurgical complications. Postoperative mortality rates were 4.9% (95% CI, 1.4-8.5) and 2.2% (95% CI, 0-4.7), respectively (P = .376).


CONCLUSIONS
The interim safety analysis failed to show any significant difference with regard to the extent of lymph node dissection. The surgical outcome was not different between the 2 surgeries.
Kulig
Jan
J
First Department of Surgery, 40 Kopernika St., 31-501 Krakow, Poland. mskulig@cyf-kr.edu.pl
Popiela
Tadeusz
T
Kolodziejczyk
Piotr
P
Sierzega
Marek
M
Szczepanik
Antoni
A
D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005743:Gastrectomy; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects* / Q000379:methods* / Q000401:mortality; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D012086:Reoperation; D013274:Stomach Neoplasms / Q000401:mortality / Q000601:surgery*; D015996:Survival Rate