Naoki Hiki1, Hitoshi Katai2, Junki Mizusawa3, Kenichi Nakamura3, Mikihito Nakamori4, Takaki Yoshikawa5, Kazuyuki Kojima6, Haruhiko Imamoto7, Motoki Ninomiya8, Seigo Kitano9, Masanori Terashima10. 1. Department of Director, Gastroenterological Surgery, Gastroenterology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. naoki.hiki@jfcr.or.jp. 2. Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan. 3. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo, Japan. 4. Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan. 5. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan. 6. Division of Gastric Surgery, Tokyo Medical and Dental University, Tokyo, Japan. 7. Faculty of Medicine, Kindai University, Higashiosaka, Japan. 8. Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan. 9. Oita University, Oita, Japan. 10. Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
Abstract
BACKGROUND:Laparoscopic gastrectomy has become a common surgical treatment for gastric cancer in eastern Asian countries. However, a large-scale prospective study to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) regarding long-term outcomes has never been reported. We have already reported the short-term outcomes of this study. Here we report long-term outcomes as the secondary endpoints of this study after a 5-year follow-up period. METHODS: This study comprised patients with clinical stageI gastric cancer who were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who had each conducted at least 30 LADG and 30 open gastrectomy procedures. The primary endpoint was the proportion of patients who developed either anastomotic leakage or pancreatic fistula. The secondary endpoints included overall survival and relapse-free survival. RESULTS:From November 2007 to September 2008, 176 eligible patients were enrolled, comprising 140 patients with pathological stage IA disease, 23 patients with pathological stage IB disease, 9 patients with pathological stage II disease, and 4 patients with pathological stage IIIA disease. No patients had recurrent disease, and three of the patients died within the follow-up period. The 5-year overall survival was 98.2% (95% confidence interval 94.4-99.4%) and the 5-year relapse-free survival was 98.2% (95% confidence interval 94.4-99.4%). CONCLUSIONS: The long-term outcomes of stage I gastric cancer patients undergoingLADG seem comparable to those of patients undergoing an open procedure, although this result should be confirmed by a randomized control trial. We have already completed accrual of 921 patients for a multicenter randomized phase III trial (JCOG0912) to confirm the noninferiority of LADG compared with open gastrectomy in terms of relapse-free survival.
RCT Entities:
BACKGROUND: Laparoscopic gastrectomy has become a common surgical treatment for gastric cancer in eastern Asian countries. However, a large-scale prospective study to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) regarding long-term outcomes has never been reported. We have already reported the short-term outcomes of this study. Here we report long-term outcomes as the secondary endpoints of this study after a 5-year follow-up period. METHODS: This study comprised patients with clinical stage I gastric cancer who were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who had each conducted at least 30 LADG and 30 open gastrectomy procedures. The primary endpoint was the proportion of patients who developed either anastomotic leakage or pancreatic fistula. The secondary endpoints included overall survival and relapse-free survival. RESULTS: From November 2007 to September 2008, 176 eligible patients were enrolled, comprising 140 patients with pathological stage IA disease, 23 patients with pathological stage IB disease, 9 patients with pathological stage II disease, and 4 patients with pathological stage IIIA disease. No patients had recurrent disease, and three of the patients died within the follow-up period. The 5-year overall survival was 98.2% (95% confidence interval 94.4-99.4%) and the 5-year relapse-free survival was 98.2% (95% confidence interval 94.4-99.4%). CONCLUSIONS: The long-term outcomes of stage I gastric cancerpatients undergoing LADG seem comparable to those of patients undergoing an open procedure, although this result should be confirmed by a randomized control trial. We have already completed accrual of 921 patients for a multicenter randomized phase III trial (JCOG0912) to confirm the noninferiority of LADG compared with open gastrectomy in terms of relapse-free survival.
Entities:
Keywords:
Gastric cancer; Laparoscopic distal gastrectomy; Long-term survival; Prospective study