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Gastrointestinal tumours, non-colorectal 1

3249 - Hybrid Minimally Invasive vs. Open Esophagectomy for patients with Esophageal Cancer: Long-term outcomes of a multicenter, open-label, randomized phase III controlled trial, the MIRO trial

Date

08 Sep 2017

Session

Gastrointestinal tumours, non-colorectal 1

Presenters

guillaume Piessen

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

C. Mariette1, S. Markar2, T.S. Dabakuyo-Yonli3, B. Meunier4, D. Pezet5, D. Collet6, X.B. D'journo7, C. Brigand8, T. Perniceni9, N. Carrere10, F. Bonnetain11, G. Piessen1

Author affiliations

  • 1 Department Of Digestive And Oncological Surgery, Claude Huriez University Hospital, 59037 - Lille/FR
  • 2 Surgery And Cancer, St. Mary's Hospital Imperial College Healthcare NHS Trust, W2 1NY - London/GB
  • 3 Biostatistics And Quality Of Life Unit , Ea4184, Centre Georges François Leclerc, 21000 - dijon/FR
  • 4 Departement Of Digestive Surgery, Pontchailloux University Hospital, 35000 - Rennes/FR
  • 5 Department Of Digestive Surgery, D'Estaing University Hospital, 63000 - Clermont Ferrand/FR
  • 6 Department Of Digestive Surgery, Haut Leveque University Hospital, 33604 - Bordeaux/FR
  • 7 Department Of Thoracic Surgery, North University Hospital, 13915 - Marseille/FR
  • 8 Department Of Digestive Surgery, Hautepierre University Hospital, 3700 - Strasbourg/FR
  • 9 Department Of Digestive Surgery, Institut Mutualiste Montsouris, 75014 - Paris/FR
  • 10 Departement Of Digestive Surgery, Purpan University Hospital, 31059 - Toulouse/FR
  • 11 Methodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, 25000 - Besançon/FR
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Resources

Abstract 3249

Background

Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy (OE). We assessed whether hybrid minimally invasive esophagectomy (HMIE) reduces morbidity compared with OE.

Methods

We performed a multicentre, open-label, randomised controlled trial at 13 study centres between October 2009 and April 2012. Patients aged 18-75 years old with resectable cancers of the middle or lower third of the oesophagus were assigned by randomisation to undergo either transthoracic OE or HMIE. Surgical quality assurance was implemented through credentialing surgeons before enrolment, standardisation of technique and monitoring of performance during the trial. HMIE comprised an Ivor Lewis procedure with laparoscopic gastric mobilisation and open right thoracotomy. The primary outcome was 30-day grade II-IV postoperative morbidity as defined by the Clavien-Dindo classification. Secondary outcomes were 30-day postoperative mortality, overall and disease free-survivals. Analysis was done by intention to treat.

Results

We randomly assigned 104 patients to the OE group and 103 to the HMIE group. Sixty-seven (64.4%) patients in the OE group had major postoperative morbidity compared with 37 (35.9%) in the HMIE group (OR 0.31, 95%CI 0.18-0.55; p 

Conclusions

These findings show that hybrid minimally invasive esophagectomy is an oncologically sound procedure, and reduces the incidence of major morbidity specifically pulmonary following esophagectomy for cancer.

Clinical trial identification

NCT00937456

Legal entity responsible for the study

Lille University Hospital

Funding

The French National Cancer Institute INCa

Disclosure

All authors have declared no conflicts of interest.

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