Methylene blue-assisted technique for harvesting lymph nodes after radical surgery for gastric cancer: a prospective randomized phase III study

BMC Cancer

Akira Tsuburaya³  Munetaka Masuda¹  Yasushi Rino¹  Takashi Oshima¹  Norio Yukawa¹  Haruhiko Cho³  Takashi Ogata³  Tsutomu Hayashi¹  Kenichi Iwasaki³  Hirohito Fujikawa¹  Junya Shirai¹  Satoshi Morita²  Takaki Yoshikawa¹  Toru Aoyama³ 

[1]Department of Surgery, Yokohama City University, Yokohama, Japan

[2]Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan

[3]Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-ku, Yokohama 241-0815, Japan

关键词: Pathology;    Gastrointestinal surgery;    Clinical trial design;   

Others  :  859001
DOI  :  10.1186/1471-2407-14-155

 received in 2013-03-19, accepted in 2014-03-03,  发布年份 2014

【 摘 要 】

Background

This randomized Phase III trial will evaluate whether the methylene blue-assisted technique is efficient for harvesting lymph nodes after radical surgery for gastric cancer.

Methods/design

Patients that undergo distal or total gastrectomy with radical nodal dissection will be randomly assigned to Group A: the standard group, the lymph nodes (LNs) will be harvested from the fresh specimen immediately after surgery, or Group B: the methylene blue-assisted group, where the LNs will be harvested from specimens fixed with 10% buffered formalin with methylene blue for 48 hours after surgery. The primary endpoint is the ratio of the number of the harvested LNs per time (minute). The secondary endpoint is the number of harvested LNs. A 25% reduction in the ratio of harvested lymph-node/time (minute) was determined to be necessary for this test treatment, considering the balance between the cost and benefit. Retrospective data was used to estimate the ratio of the number of the harvested LNs per time (minute) to be 40/30 minutes in Group A. A 25% risk reduction and a rate of 40/22.5 minutes is expected in Group B. Therefore, the sample size required ensuring a two-sided alpha error of 5% and statistical power of 80% is 52 patients, with 26 patients per arm. The number of patients to be accrued was set at 60 in total, due to the likelihood of enrolling ineligible patients.

Trial registration

UMIN000008624

【 授权许可】

   
2014 Aoyama et al.; licensee BioMed Central Ltd.

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