title: Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol.
abstract: Along with the marked increase in early gastric cancer (EGC) in the Eastern countries, there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications. Based on promising results from a previous quality control study, this prospective multicenter randomized controlled phase III clinical trial aims to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to a standard laparoscopic gastrectomy.
  
  
  
  This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma, with a diameter of 3 cm or less are eligible for the present study. A total of 580 patients (290 per group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, 5-year DFS, and overall survival. Qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial.
  
  
  
  The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves similar oncologic outcomes and improved quality of life compared to a standard gastrectomy in EGC patients.
  
  
  
  This study was registered at the NIH ClinicalTrial.gov database ( NCT01804998 ) on March 4th, 2013.
authors.affiliation: Department of Surgery, National Cancer Center, Goyang, Republic of Korea.|Present address: Department of Surgery, Kyungpook National University Medical Center, Daegu, Korea.
authors.forename: Ji Yeon
authors.initials: JY
authors.lastname: Park
authors.affiliation: Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang, Gyeonggi-do, 10408, Republic of Korea.
authors.forename: Young-Woo
authors.initials: YW
authors.lastname: Kim
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.
authors.forename: Keun Won
authors.initials: KW
authors.lastname: Ryu
authors.affiliation: Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang, Gyeonggi-do, 10408, Republic of Korea. byunghonam@ncc.re.kr.
authors.forename: Byung-Ho
authors.initials: BH
authors.lastname: Nam
authors.affiliation: Department of Surgery, Gyeongsang National University, Jinju, Korea.
authors.forename: Young Joon
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: Department of Surgery, Gyeongsang National University, Jinju, Korea.
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Jeong
authors.affiliation: Department of Surgery, Gyeongsang National University, Jinju, Korea.
authors.forename: Ji-Ho
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Hoon
authors.initials: H
authors.lastname: Hur
authors.affiliation: Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Sang-Uk
authors.initials: SU
authors.lastname: Han
authors.affiliation: Department of Surgery, Dongnam Institute of Radiological and Medical Science, Busan, Korea.
authors.forename: Jae Seok
authors.initials: JS
authors.lastname: Min
authors.affiliation: Department of Surgery, Yonsei University School of Medicine, Seoul, Korea.|Present address: Department of Surgery, Samsung Medical Center, Seoul, Korea.
authors.forename: Ji Yeong
authors.initials: JY
authors.lastname: An
authors.affiliation: Department of Surgery, Yonsei University School of Medicine, Seoul, Korea.
authors.forename: Woo Jin
authors.initials: WJ
authors.lastname: Hyung
authors.affiliation: Department of Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea.
authors.forename: Gyu Seok
authors.initials: GS
authors.lastname: Cho
authors.affiliation: Department of Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea.
authors.forename: Gui Ae
authors.initials: GA
authors.lastname: Jeong
authors.affiliation: Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Korea.
authors.forename: Oh
authors.initials: O
authors.lastname: Jeong
authors.affiliation: Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Korea.
authors.forename: Young Kyu
authors.initials: YK
authors.lastname: Park
authors.affiliation: Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Korea.
authors.forename: Mi Ran
authors.initials: MR
authors.lastname: Jung
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.
authors.forename: Hong Man
authors.initials: HM
authors.lastname: Yoon
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.
authors.forename: Bang Wool
authors.initials: BW
authors.lastname: Eom
mesh_terms: D000328:Adult; D000368:Aged; D024221:Antineoplastic Protocols; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008197:Lymph Node Excision / Q000379:methods; D008297:Male; D008875:Middle Aged; D012107:Research Design; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013274:Stomach Neoplasms / Q000601:surgery*
keywords: Gastric cancer; Laparoscopic surgery; Phase III clinical trial; Sentinel lymph node