Randomised oesophagectomy: minimally invasive or open - comparing different approaches to surgery

INTERVENTION: Patients will be randomised to either open oesophagectomy (OO) or "laparoscopically assisted" oesophagectomy (LAO) using an internet‐based randomisation system. Both treatments are provided as standard on the NHS. OO and LAO both consist of identical steps, except that the abdominal phase of the operation in the LAO group will be done through several smaller cuts to the tummy and performed laparoscopically. The duration of treatment is the duration of surgery. Patients will be followed up using questionnaires for 24‐36 months after randomisation into the study (36 month follow‐up will only be completed if it falls within the planned length of the study). Added 18/08/2017: In Bristol and Southampton patients may be randomised to a third group ‐ Totally Minimally Invasive Oesophagectomy (TMIO). The ROMIO study includes a nested IDEAL Phase 2b study looking at TMIO. CONDITION: Specialty: Cancer, Primary sub‐specialty: Upper GI; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs ; Cancer ; Oesophageal cancer PRIMARY OUTCOME: Assessment of physical function, using the mean of a subscale of the EORTC QLQ‐C30, carried out at three and six weeks post‐surgery and three months after randomisation SECONDARY OUTCOME: 1. All cause short and long term complications; 2. Impact of the 30‐day complications will be categorised using the Clavien‐Dindo System; 3. Lung function is measured using spirometry measures of forced expiratory volume 1 and forced vital capacity; 4. Success of blinding during the first six days post‐surgery is determined using the Bang Blinding Index procedure; 5. Generic and disease specific health‐related quality of life measures are determined using EORTC QLQ‐C30 and QLQ‐OES18, multidimensional fatigue inventory (MFI‐20), EuroQOLEQ‐5D‐5L; 6. Quality assurance of surgery with histopathological and surgical measures; 6.1. Histopathological measures (with the pathologist assessing these blind to treatment allocation); 6.1.1. Length of the oesophagus; 6.1.2. Total count of malignant ‘positive’ nodes; 6.1.3. Total count of all nodes; 6.1.4. Rates of positive circumferential resection margins; 6.1.5. Rates of positive proximal and distal resection margins; 6.1.6. pT stage (proportions of patients with each pT stage); 6.2. Surgical measures assessed by a surgeon blind to patient allocation; 6.2.1. Quality of abdominal lymphadenectomy; 6.2.2. Quality of mediastinal lymphadenectomy; 7. Overall and disease‐free survival to 2‐years; 8. Length of hospital stay, defined as length of primary hospital stage plus readmission within 30 days (and length of primary hospital stay plus length of hospital stay if discharged to community hospital). ; 9. Further measures of resource use including: staff time and resources used in theatre in the interventions; subsequent inpatient stays, outpatient visits, general practitioner visits and other community based resource use INCLUSION CRITERIA: 1. 18 years of age or above 2. Referred for primary oesophagectomy by the multi‐disciplinary team (MDT) or oesophagectomy following re‐staging after neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy (N.B, in this any type of neoadjuvant treatment may be used) 3. Confirmed MDT evidence of at least adenocarcinoma or at least squamous cell cancer of the oesophagus or oesophago‐gastric junction 4. Fit for pre‐operative anaesthesia and surgery, assessed by the MDT 5. Able to provide written informed consent 6. Measurement (endoscopic or otherwise) that the tumour starts more than 5 cm below crico‐pharyngeus 7. Measurement (endoscopic or otherwise) that the tumour involves less than 4 cm of the gastric wall 8. The final pre‐treatment tumour stage is between T1N0M0 and T4aN1M0, i.e. including all stages (T1N0M0, T1N1M0, T1N2M0, T2N0M0, T2N1M0, T2N2M0, T3N0M0, T3N1M0, T3N2M0, T4aN0M0 and T4aN1M0) in which T4a is a resectable tumour invading ple