Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial
The Lancet, 05/22/2012
Biere SS et al. – These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer.Methods
- We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011.
- Patients aged 18—75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated randomisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy.
- Randomisation was stratified by centre.
- Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment.
- The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital.
- Analysis was by intention to treat.
- We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group.
- 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk [RR] 0·30, 95% CI 0·12—0·76; p=0·005).
- 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16—0·78; p=0·005).
- For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage.