Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
30470
Study information
Scientific title
ROMIO: Randomised Oesophagectomy - Minimally Invasive or Open
Acronym
ROMIO
Study hypothesis
Laparoscopically-assisted oesophagectomy (LAO) is superior compared to standard open oesophagectomy (OO) with respect to recovery from surgery.
Ethics approval
South West Frenchay Research Ethics Committee, 11/05/2016, ref:L 16/SW/0098
Study design
Both; Both; Design type: Treatment, Surgery, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Upper GI; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs
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.
Intervention type
Other
Phase
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/12/2015
Overall trial end date
30/05/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 446; UK Sample Size: 446
Participant 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
Recruitment start date
01/06/2016
Recruitment end date
01/12/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Royal Infirmary
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom
Trial participating centre
Derriford Hospital
Plymouth Hospitals NHS Foundation Trust
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Trial participating centre
Southampton General Hospital
University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Royal Infirmary of Edinburgh
NHS Lothian
GI Surgery
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Leicester Royal Infirmary
University Hospitals of Leicester NHS Trust#
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Trial participating centre
Royal Preston Hospital
Lancashire Teaching Hospitals NHS Foundation Trust
Chief Executive's Office
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
Trial participating centre
Salford Royal
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
Trial participating centre
Nottingham City Hospital
Upper GI Surgery
City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned dissemination of the main trial results (clinical and cost-effectiveness) to surgeons and other clinicians through publication in a high profile journal which allows open access (to be published after the study has ended). This will be preceded by publication of the design of the definitive trial, allowing a fuller description of the methods, so enabling better understanding of the results. The study and results will also be disseminated at conferences attended by surgeons, such as the annual Association of Upper Gastro Intestinal Surgeons (AUGIS) meeting, and the NCRI Upper GI Clinical Studies Group Annual Trials Meeting.
IPD sharing statement
The datasets generated during and/or analysed during the current study will not be made available for sharing until after publication of the main results of the research. Thereafter, anonymised individual patient data will be made available for secondary research, conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the MRC Policy on Data Preservation and Sharing regarding scientific quality, ethical requirements and value for money. A minimum requirement with respect to scientific quality will be a publicly available pre-specified protocol describing the purpose, methods and analysis of the secondary research, e.g. a protocol for a Cochrane systematic review. The second file containing patient identifiers would be made available for record linkage or a similar purpose, subject to confirmation that the secondary research protocol has been approved by a UK REC or other similar, approved ethics review body.
Intention to publish date
30/05/2022
Participant level data
Available on request
Basic results (scientific)
Publication list