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Open Access Highly Accessed Study protocol

Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial

Nicolas Briez12, Guillaume Piessen12, Franck Bonnetain3, Cécile Brigand4, Nicolas Carrere5, Denis Collet6, Christophe Doddoli7, Renaud Flamein8, Jean-Yves Mabrut9, Bernard Meunier10, Simon Msika11, Thierry Perniceni12, Frédérique Peschaud13, Michel Prudhomme14, Jean-Pierre Triboulet12 and Christophe Mariette12*

Author Affiliations

1 Department of Digestive and Oncological Surgery, University Hospital, Place de Verdun, Lille, F-59037, France

2 Faculty of Medicine Henri Warembourg, University of Lille 2, Lille, F-59045, France

3 Biostatistic and Epidemiological Unit, EA 4184, Centre Georges François Leclerc, 1 rue du Pr Marion, Dijon, F-21079, France

4 Department of Digestive Surgery, University Hospital, Avenue Molière, Strasbourg, F-67200, France

5 Department of Digestive Surgery, Purpan University Hospital, Place du Dr Baylac, Toulouse, F-31059, France

6 Department of Digestive Surgery, Pessac University Hospital, Avenue de Magellan Bordeaux, F-33604, France

7 Department of Digestive Surgery, Nord University Hospital, Chemin des Bourrely, Marseille, F-13915, France

8 Department of Digestive Surgery, University Hospital, Boulevard Montalembert, Clermont-Ferrand, F-63003, France

9 Department of Digestive Surgery, Croix-Rousse University Hospital, Grande Rue de la Croix Rousse, Lyon, F-69004, France

10 Department of Digestive Surgery, Pontchaillou University Hospital, Rue Henri Le Guilloux, Rennes, F-35033, France

11 Department of Digestive Surgery, Louis Mourrier University Hospital, Rue des Renouillers, Colombes, F-92701, France

12 Department of Digestive Surgery, Institut Mutualiste Montsouris, Boulevard Jourdan, Paris, F-75014, France

13 Department of Digestive Surgery, Ambroise Paré University Hospital, Boulevard Charles de Gaulle, Boulogne Billancourt, F-92104, France

14 Department of Digestive Surgery, University Hospital, Place du Pr Robert Debré, Nîmes, F-30029, France

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BMC Cancer 2011, 11:310  doi:10.1186/1471-2407-11-310

Published: 23 July 2011

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/Design

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.

Discussion

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.

Trial Registration

NCT00937456 (ClinicalTrials.gov)

Keywords:
oesophageal cancer; surgery; minimally invasive surgery; oesophagectomy; randomised controlled trial