title: Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial.
abstract: BACKGROUND
  Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy.
  
  
  METHODS
  We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011. Patients aged 18-75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated randomisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy. Randomisation was stratified by centre. Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment. The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452.
  
  
  RESULTS
  We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group. 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk [RR] 0·30, 95% CI 0·12-0·76; p=0·005). 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16-0·78; p=0·005). For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage.
  
  
  CONCLUSIONS
  These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer.
  
  
  BACKGROUND
  Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre.
authors.affiliation: Department of Surgery, VU University Medical Centre, Amsterdam, Netherlands.
authors.forename: Surya S A Y
authors.initials: SS
authors.lastname: Biere
authors.forename: Mark I
authors.initials: MI
authors.lastname: van Berge Henegouwen
authors.forename: Kirsten W
authors.initials: KW
authors.lastname: Maas
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.forename: Josep Roig
authors.initials: JR
authors.lastname: Garcia
authors.forename: Suzanne S
authors.initials: SS
authors.lastname: Gisbertz
authors.forename: Jean H G
authors.initials: JH
authors.lastname: Klinkenbijl
authors.forename: Markus W
authors.initials: MW
authors.lastname: Hollmann
authors.forename: Elly S M
authors.initials: ES
authors.lastname: de Lange
authors.forename: H Jaap
authors.initials: HJ
authors.lastname: Bonjer
authors.forename: Donald L
authors.initials: DL
authors.lastname: van der Peet
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Cuesta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy / Q000379:methods*; D004943:Esophagogastric Junction / Q000601:surgery*; D004945:Esophagoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D007902:Length of Stay; D008171:Lung Diseases / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011788:Quality of Life; D012141:Respiratory Tract Infections / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult