title: Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial.
abstract: BACKGROUND
  Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation) in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma.
  
  
  METHODS
  The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A.
  
  
  CONCLUSIONS
  Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery.
  
  
  BACKGROUND
  NCT00937456 (ClinicalTrials.gov).
authors.affiliation: Department of Digestive and Oncological Surgery, University Hospital, Place de Verdun, Lille, F-59037, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Briez
authors.forename: Guillaume
authors.initials: G
authors.lastname: Piessen
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Cécile
authors.initials: C
authors.lastname: Brigand
authors.forename: Nicolas
authors.initials: N
authors.lastname: Carrere
authors.forename: Denis
authors.initials: D
authors.lastname: Collet
authors.forename: Christophe
authors.initials: C
authors.lastname: Doddoli
authors.forename: Renaud
authors.initials: R
authors.lastname: Flamein
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mabrut
authors.forename: Bernard
authors.initials: B
authors.lastname: Meunier
authors.forename: Simon
authors.initials: S
authors.lastname: Msika
authors.forename: Thierry
authors.initials: T
authors.lastname: Perniceni
authors.forename: Frédérique
authors.initials: F
authors.lastname: Peschaud
authors.forename: Michel
authors.initials: M
authors.lastname: Prudhomme
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Triboulet
authors.forename: Christophe
authors.initials: C
authors.lastname: Mariette
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery*; D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000601:surgery*; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy / Q000379:methods*; D004947:Esophagus / Q000473:pathology / Q000601:surgery; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D010535:Laparoscopy; D008197:Lymph Node Excision; D008875:Middle Aged; D011182:Postoperative Care; D011300:Preoperative Care; D011446:Prospective Studies; D013270:Stomach / Q000601:surgery; D013908:Thoracotomy; D055815:Young Adult