title: Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912.
abstract: BACKGROUND
  No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy.
  
  
  METHODS
  We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG. This study is now in the follow-up stage. The primary endpoint is relapse-free survival (RFS) and the primary analysis is planned in 2018. Here, we compared the surgical outcomes of the two groups. This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319.
  
  
  RESULTS
  Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operative time was longer in LADG than in ODG (median 278 vs. 194 min, p < 0.001), while blood loss was smaller (median 38 vs. 115 ml, p < 0.001). There was no difference in the overall proportion with in-hospital grade 3-4 surgical complications (3.3 %: LADG, 3.7 %: ODG). The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG (16.4 vs. 5.3 %, p < 0.001). There was no operation-related death in either arm.
  
  
  CONCLUSIONS
  This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes. LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed.
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, chuo-ku, Tokyo, 104-0045, Japan. hkatai@ncc.go.jp.
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: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Takagi
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Fukagawa
authors.affiliation: Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Kazunari
authors.initials: K
authors.lastname: Misawa
authors.affiliation: Department of Surgery, National Hospital Organization, Sendai Medical Center, Sendai, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Teshima
authors.affiliation: Department of Surgery, Iwate Medical University, Morioka, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Koeda
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Hospital, Tokyo, Japan.
authors.forename: Souya
authors.initials: S
authors.lastname: Nunobe
authors.affiliation: Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
authors.forename: Norimasa
authors.initials: N
authors.lastname: Fukushima
authors.affiliation: Department of Gastroenterological Surgery, Hyogo Cancer Center, Akashi, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yasuda
authors.affiliation: Department of Gastroenterological Surgery, Tenri Hospital, Tenri, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Asao
authors.affiliation: Department of Gastroenterological Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Fujiwara
authors.affiliation: Division of Upper Gastrointestinal Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D007564:Japan; D010535:Laparoscopy / Q000379:methods; D008197:Lymph Node Excision / Q000379:methods; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome
keywords: Clinical trial; Gastrectomy; Gastric cancer; Laparoscopic surgery; Phase III