title: A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901).
abstract: BACKGROUND
  The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated.
  
  
  METHODS
  Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0-2 and M0. Patients aged 20-80 years were pre-operatively randomized.
  
  
  RESULTS
  In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwent laparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge.
  
  
  CONCLUSIONS
  The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 ( www.umin.ac.jp/ctr/).
authors.affiliation: Department of Gastroenterological Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Inaki
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Hasama-machi, Oita, 879-5593, Japan. teto@oita-u.ac.jp.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Etoh
authors.affiliation: Department of Mathematics and Statistics, Oita University Faculty of Medicine, Oita, Japan.
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Ohyama
authors.affiliation: Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki, Japan.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Uchiyama
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Natsuya
authors.initials: N
authors.lastname: Katada
authors.affiliation: Department of Surgery, Iwate Medical University School of Medicine, Morioka, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Koeda
authors.affiliation: Department of Surgical Oncology, Gifu University, Gifu, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.
authors.forename: Akinori
authors.initials: A
authors.lastname: Takagane
authors.affiliation: Center for Minimally Invasive Surgery, Tokyo Medical and Dental University, Bunkyō, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Kojima
authors.affiliation: Department of Gastroenterological Surgery, Comprehensive Cancer Center, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sakuramoto
authors.affiliation: Center for Community Medicine, Oita University Faculty of Medicine, Oita, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Shiraishi
authors.affiliation: Oita University, Oita, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Kitano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057868:Anastomotic Leak / Q000209:etiology; D061887:Conversion to Open Surgery; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects* / Q000379:methods; D005763:Gastroenterostomy; D006801:Humans; D007431:Intraoperative Complications / Q000601:surgery; D010535:Laparoscopy / Q000009:adverse effects* / Q000379:methods; D008197:Lymph Node Excision / Q000009:adverse effects* / Q000379:methods; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D010185:Pancreatic Fistula / Q000209:etiology*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology* / Q000601:surgery*; D016896:Treatment Outcome