title: The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial.
abstract: The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy.
  
  
  
  The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes).
  
  
  
  The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety.
  
  
  
  ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Jun-Yang
authors.initials: JY
authors.lastname: Lu
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Lai
authors.initials: L
authors.lastname: Xu
authors.affiliation: Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Hua-Dan
authors.initials: HD
authors.lastname: Xue
authors.affiliation: Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Wei-Xun
authors.initials: WX
authors.lastname: Zhou
authors.affiliation: Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences/School of Basic Medicine, Peking Union Medical College, #5 Dongdan San Tiao, Beijing, 100005, People's Republic of China.
authors.forename: Tao
authors.initials: T
authors.lastname: Xu
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Hui-Zhong
authors.initials: HZ
authors.lastname: Qiu
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Bin
authors.initials: B
authors.lastname: Wu
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China.
authors.forename: Guo-Le
authors.initials: GL
authors.lastname: Lin
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #1 Shuai Fu Yuan Street, Beijing, 100730, People's Republic of China. xiaoy@pumch.cn.
authors.forename: Yi
authors.initials: Y
authors.lastname: Xiao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China; D002985:Clinical Protocols; D003082:Colectomy / Q000009:adverse effects / Q000379:methods*; D003110:Colonic Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D008197:Lymph Node Excision / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D008198:Lymph Nodes / Q000473:pathology / Q000601:surgery*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Colon cancer; Complete mesocolic excision; Laparoscopic right colectomy; Oncological outcome