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Japanese Journal of Clinical Oncology Advance Access published online on June 26, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn054
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© The Author (2008). Published by Oxford University Press. All rights reserved

Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

Seiichiro Yamamoto1, Kenichi Yoshimura2, Fumio Konishi3 and Masahiko Watanabe4

1 Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo
2 Biostatistics and Epidemiology Section, Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center Research Institute, Tokyo
3 Department of Gastroenterology, Jichi Medical University, Omiya Medical Center, Saitama
4 Department of Surgery, Kitasato University Hospital, Kanagawa, Japan

For reprints and all correspondence: Seiichiro Yamamoto, Division of Colorectal Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: seyamamo{at}ncc.go.jp

Received March 17, 2008; accepted May 30, 2008

Recently reported randomized controlled trials demonstrated that laparoscopic surgery (LS) was comparable or superior to open surgery with regard to the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists with regard to the appropriateness of LS for patients with rectal carcinoma. To examine the technical and oncological feasibility of LS for rectal carcinoma, a phase II trial was started in patients with a preoperative diagnosis of Stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery. Surgeons in 39 specialized institutions will recruit 350 patients. The primary end-point in the first stage is the anastomotic leakage rate by double-stapling technique and that in the second stage is overall survival. Secondary end-points are relapse-free survival, short-term clinical outcome, adverse events, the rate of histologically curative operation, the proportion of completion of LS and the conversion rate.

Key Words: laparoscopic surgery • rectal carcinoma • phase II trial


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