Standard D2 versus extended D2 (D2+) lymphadenectomy for gastric cancer: an interim safety analysis of a multicenter, randomized, clinical trial

Abstract 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 Associat...

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Bibliographic Details
Published in:The American journal of surgery 2007, Vol.193 (1), p.10-15
Main Authors: Kulig, Jan, Ph.D, Popiela, Tadeusz, Ph.D, Kolodziejczyk, Piotr, Ph.D, Sierzega, Marek, M.D, Szczepanik, Antoni, Ph.D
Format: Article
Language:English
Subjects:
Abdomen
Adenocarcinoma - mortality
Adenocarcinoma - secondary
Adenocarcinoma - surgery
Adult
Aged
Aged, 80 and over
Antibiotics
Biological and medical sciences
Classification
Clinical trials
Complications
Dissection
Female
Gastrectomy
Gastric cancer
Gastroenterology. Liver. Pancreas. Abdomen
Gastrointestinal surgery
General aspects
Humans
Lymph Node Excision - adverse effects
Lymph Node Excision - methods
Lymph Node Excision - mortality
Lymphadenectomy
Lymphatic Metastasis
Lymphatic system
Male
Medical sciences
Middle Aged
Mortality
Reoperation
Respiratory system
Stomach Neoplasms - mortality
Stomach Neoplasms - surgery
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Surgery
Surgical outcomes
Survival Rate
Tumors
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Summary:Abstract 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.
ISSN:0002-9610
1879-1883
DOI:10.1016/j.amjsurg.2006.04.018