title: Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001).
abstract: OBJECTIVE
  Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer.
  
  
  METHODS
  Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopy-assisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation.
  
  
  CONCLUSIONS
  Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer.
  
  
  BACKGROUND
  NCT01088204 (international), NCCCTS-09-448 (Korea).
authors.affiliation: Biometric Research Branch, Research Institute for National Cancer Control & Evaluation, National Cancer Center, Goyang, Korea.
authors.forename: Byung Ho
authors.initials: BH
authors.lastname: Nam
authors.forename: Young-Woo
authors.initials: YW
authors.lastname: Kim
authors.forename: Daniel
authors.initials: D
authors.lastname: Reim
authors.forename: Bang Wool
authors.initials: BW
authors.lastname: Eom
authors.forename: Wan Sik
authors.initials: WS
authors.lastname: Yu
authors.forename: Young Kyu
authors.initials: YK
authors.lastname: Park
authors.forename: Keun Won
authors.initials: KW
authors.lastname: Ryu
authors.forename: Young Joon
authors.initials: YJ
authors.lastname: Lee
authors.forename: Hong Man
authors.initials: HM
authors.lastname: Yoon
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Lee
authors.forename: Oh
authors.initials: O
authors.lastname: Jeong
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Jeong
authors.forename: Sang Eok
authors.initials: SE
authors.lastname: Lee
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Lee
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Yoon
authors.forename: Kyung Won
authors.initials: KW
authors.lastname: Seo
authors.forename: Ho Young
authors.initials: HY
authors.lastname: Chung
authors.forename: Oh Kyoung
authors.initials: OK
authors.lastname: Kwon
authors.forename: Tae Bong
authors.initials: TB
authors.lastname: Kim
authors.forename: Woon Ki
authors.initials: WK
authors.lastname: Lee
authors.forename: Seong Heum
authors.initials: SH
authors.lastname: Park
authors.forename: Ji-Young
authors.initials: JY
authors.lastname: Sul
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yang
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
keywords: Gastrectomy; Lymph node excision; Stomach neoplasms