title: Early phase II study of robot-assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer.
abstract: BACKGROUND
  Robot-assisted distal gastrectomy (RADG) is increasingly performed in Japan and Korea and is thought to have many advantages over laparoscopic gastrectomy. However, a prospective study investigating the safety of RADG has never been reported. The present study evaluated the safety of RADG with nodal dissection for clinical stage IA gastric cancer.
  
  
  METHODS
  This single-center, prospective phase II study included patients with clinical stage IA gastric cancer located within the lower two-thirds of the stomach. The primary endpoint was the incidence of postoperative intraabdominal infectious complications including anastomotic leakage, pancreas-related infection, and intraabdominal abscess. The secondary endpoints included all in-hospital adverse events, RADG completion rate, and survival outcome.
  
  
  RESULTS
  From May 2012 to November 2012, 18 eligible patients were enrolled for this study. The incidence of intraabdominal infectious complication was 0 % (90 % CI, 0-12.0 %). The overall incidence of in-hospital adverse events was 22.2 % (90 % CI, 8.0-43.9 %). No patient required conversion to laparoscopic or open gastrectomy; thus, the RADG completion rate was 100 %.
  
  
  CONCLUSIONS
  This early phase II study suggested that RADG might be a safe and feasible procedure for stage IA gastric cancer, providing experienced surgeons perform the surgery. This conclusion should be clarified in subsequent late phase II studies with a larger sample size.
authors.affiliation: Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Tokunaga
authors.forename: Norihiko
authors.initials: N
authors.lastname: Sugisawa
authors.forename: Junya
authors.initials: J
authors.lastname: Kondo
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tanizawa
authors.forename: Etsuro
authors.initials: E
authors.lastname: Bando
authors.forename: Taiichi
authors.initials: T
authors.lastname: Kawamura
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D015994:Incidence; D008197:Lymph Node Excision / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D012371:Robotics; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis