title: Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial.
abstract: BACKGROUND
  Oesophageal cancer is the eighth most common cause of cancer worldwide. In 2009 in China, the incidence and death rate of oesophageal cancer was 22.14 per 100 000 person-years and 16.77 per 100 000 person-years, respectively, the highest in the world. Minimally invasive oesophagectomy (MIO) was introduced into clinical practice with the aim of reducing the morbidity rate. The mechanisms of MIO may lie in minimising the reaction to surgical injury and inflammation. There are some randomised trials regarding minimally invasive versus open oesophagectomy, with 100-850 subjects enrolled. To date, no large randomised controlled trial comparing minimally invasive versus open oesophagectomy has been reported in China, where squamous cell carcinoma predominated over adenocarcinoma of the oesophagus.
  
  
  METHODS
  This is a 3 year multicentre, prospective, randomised, open and parallel controlled trial, which aims to compare the effectiveness of minimally invasive thoraco-laparoscopic oesophagectomy to open three-stage transthoracic oesophagectomy for resectable oesophageal cancer. Group A patients receive MIO which involves thoracoscopic oesophagectomy and laparoscopic gastric mobilisation with cervical anastomosis. Group B patients receive the open three-stage transthoracic oesophagectomy which involves a right thoracotomy and laparotomy with cervical anastomosis. Primary endpoints include respiratory complications within 30 days after operation. The secondary endpoints include other postoperative complications, influences on pulmonary function, intraoperative data including blood loss, operative time, the number and location of lymph nodes dissected, and mortality in hospital, the length of hospital stay, total expenses in hospital, mortality within 30 days, survival rate after 2 years, postoperative pain, and health-related quality of life (HRQoL). Three hundred and twenty-four patients in each group will be needed and a total of 648 patients will finally be enrolled into the study.
  
  
  BACKGROUND
  The study protocol has been approved by the Institutional Ethics Committees of all participating institutions. The findings of this trial will be disseminated to patients and through peer-reviewed publications and international presentations.
  
  
  BACKGROUND
  NCT02355249.
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Juwei
authors.initials: J
authors.lastname: Mu
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Shugeng
authors.initials: S
authors.lastname: Gao
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Yousheng
authors.initials: Y
authors.lastname: Mao
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Qi
authors.initials: Q
authors.lastname: Xue
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Zuyang
authors.initials: Z
authors.lastname: Yuan
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Li
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Su
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Kun
authors.initials: K
authors.lastname: Yang
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Lv
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Qiu
authors.affiliation: Department of Thoracic Surgery, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Deruo
authors.initials: D
authors.lastname: Liu
authors.affiliation: Department of Thoracic Surgery, Peking University Cancer Hospital, Beijing, China.
authors.forename: Keneng
authors.initials: K
authors.lastname: Chen
authors.affiliation: Department of Thoracic Surgery, Beijing Chao-Yang Hospital, Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Thoracic Surgery, Peking University Third Hospital, Beijing, China.
authors.forename: Tiansheng
authors.initials: T
authors.lastname: Yan
authors.affiliation: Department of Thoracic Surgery, The Sichuan Province Cancer Hospital, Sichuan, China.
authors.forename: Yongtao
authors.initials: Y
authors.lastname: Han
authors.affiliation: Department of Thoracic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Du
authors.affiliation: Department of Thoracic Surgery, Quanzhou First Hospital, Fujian, China.
authors.forename: Rongyu
authors.initials: R
authors.lastname: Xu
authors.affiliation: Department of Thoracic Surgery, The People's Hospital Of Guangxi Zhuang Autonomous Region, Guangxi, China.
authors.forename: Zhaoke
authors.initials: Z
authors.lastname: Wen
authors.affiliation: Department of Thoracic Surgery, Hunan Province Cancer Hospital, Hunan, China.
authors.forename: Wenxiang
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Thoracic Surgery, Nantong Cancer Hospital, Jiangsu, China.
authors.forename: Mingxin
authors.initials: M
authors.lastname: Shi
authors.affiliation: Department of Thoracic Surgery, Jiangxi Province People's Hospital, Jiangxi, China.
authors.forename: Quan
authors.initials: Q
authors.lastname: Xu
authors.affiliation: Department of Thoracic Surgery, The First Hospital of China Medical University, Liaoning, China.
authors.forename: Shun
authors.initials: S
authors.lastname: Xu
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: He
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China / Q000453:epidemiology; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy / Q000379:methods*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D010535:Laparoscopy / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult