title: Long-term outcomes of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG0703).
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 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 cancer patients 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.
authors.affiliation: 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.
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiki
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Katai
authors.affiliation: Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.
authors.forename: Mikihito
authors.initials: M
authors.lastname: Nakamori
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.affiliation: Division of Gastric Surgery, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Kojima
authors.affiliation: Faculty of Medicine, Kindai University, Higashiosaka, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Imamoto
authors.affiliation: Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
authors.forename: Motoki
authors.initials: M
authors.lastname: Ninomiya
authors.affiliation: Oita University, Oita, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Kitano
authors.affiliation: Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D053208:Kaplan-Meier Estimate; D010535:Laparoscopy / Q000379:methods*; D008197:Lymph Node Excision / Q000379:methods; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D013995:Time; D055815:Young Adult
keywords: Gastric cancer; Laparoscopic distal gastrectomy; Long-term survival; Prospective study