Oesophageal cancer Cancer Malignant neoplasm of oesophagus
Conditions
Interventions
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 standar
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
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 pleura, pericardium, or diaphragm
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 18/08/2017: 1. Patients with high grade dysplasia (squamous cell or adenocarcinoma) 2. Patients with T4b, or any stage with M1 3. Type 3 tumours of the oesophago-gastric junction that are scheduled for total gastrectomy 4. Patients with squamous cell cancer of the oesophagus who the MDT recommends or who individually elect to undergo definitive chemoradiotherapy 5. Evidence of previous complex thoracotomies or laparotomies that preclude a minimal access approach 6. Evidence of previous/concomitant malignancy that would interfere with this treatment protocol 7. Pregnancy 8. Patients participating in other trials that would interfere with the implementation of this protocol at a particular site Previous exclusion criteria: 1. Patients with high grade dysplasia (squamous cell or adenocarcinoma) 2. Stage 4 disease 3. Type 3 tumours of the oesophago-gastric junction that are scheduled for total gastrectomy 4. Patients with squamous cell cancer of the oesophagus who the MDT recommends or who individually elect to undergo definitive chemoradiotherapy 5. Evidence of previous complex thoracotomies or laparotomies that preclude a minimal access approach 6. Evidence of previous/concomitant malignancy that would interfere with this treatment protocol 7. Pregnancy 8. Patients participating in other trials that would interfere with the implementation of this protocol at a particular site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of physical function, using the mean of a subscale of the EORTC QLQ-C30, carried out at 3 and 6 weeks post-surgery and 3 months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 6 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 | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactChris Metcalfe
Outcome results
None listed