Hybrid minimally invasive versus open oesophagectomy for patients with oesophageal cancer: A multicenter, open-label, randomized phase III controlled trial, the MIRO trial.

Abstract

5 Background: Surgical resection is regarded as the only curative option for resectable oesophageal cancer. Postoperative morbidity, in particular pulmonary complications, continues to be of great concern and occurs in more than half of patients after open oesophagectomy (OO). We assessed whether hybrid minimally invasive oesophagectomy (HMIO) reduces morbidity compared with OO. Methods: We performed a multicentre, open-label, randomised controlled trial at 12 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 a computer-generated randomisation sequence to undergo either transthoracic OO or HMIO. Surgical technique was standardised by both on site visits and the use of videos, and was based on an Ivor Lewis procedure with laparoscopic gastric mobilisation and open right thoracotomy. Randomisation was stratified by centre. The primary outcome was 30 day grade II-IV postoperative morbidity as defined by the Dindo-Clavien classification. Analysis was by intention to treat. Results: We randomly assigned 104 patients to the OO group and 103 to the HMIO group. Sixty-seven (64.4%) patients in the OO group had major postoperative morbidity compared with 37 (35.9%) in the HMIO group (OR 0·31, 95% CI 0·18-0·55; p=0·0001). Thirty-one (30.1%) patients in the OO had major pulmonary complications compared with 18 (17.7%) in the minimally invasive group p=0·037), whereas 30-day mortality was 5 (4.9%) vs. 5 (4.9%), respectively. Conclusions: These findings provide evidence for the short-term benefits of HMIO for patients with resectable oesophageal cancer (NCT00937456 ClinicalTrials.gov). Clinical trial information: NCT00937456.