Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial

Summary

Background

Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy.

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. This trial is registered with the Netherlands Trial Register, NTR TC 2452.

Findings

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.

Interpretation

These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer.

Funding

Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre.

Introduction

The global incidence of oesophageal cancer has increased by 50% in the past two decades, from 316 000 people diagnosed in 1990 to 482 300 new cases recorded in 2008.1, 2 Surgical resection with radical lymphadenectomy, usually after neoadjuvant chemotherapy or chemoradiotherapy, is regarded as the only curative option for resectable oesophageal cancer.3, 4, 5

Mortality rates in oesophageal resection are less than 5%.⁶ However, at least half the patients who have open oesophagectomy, performed through a right thoracotomy and laparotomy, are at risk for developing pulmonary complications that need protracted stay in intensive-care units and hospitals, with subsequent consequences for quality of life during convalescence.⁶ Minimally invasive oesophagectomy, avoiding thoracotomy and laparotomy, can reduce the rate of pulmonary infections, thus reducing stay in hospital.7, 8 Because of these potential advantages, minimally invasive oesophagectomy is being increasingly implemented; however, no randomised trials have investigated the benefits of this technique.9, 10 We compared open with minimally invasive oesophagectomy in patients with oesophageal cancer to assess the rate of pulmonary infections and quality of life associated with the minimally invasive procedure.