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

Abstract

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.