Randomised oesophagectomy: minimally invasive or open - comparing different approaches to surgery
ISRCTN | ISRCTN10386621 |
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DOI | https://doi.org/10.1186/ISRCTN10386621 |
IRAS number | 184167 |
Secondary identifying numbers | 30470 |
- Submission date
- 18/05/2016
- Registration date
- 31/05/2016
- Last edited
- 26/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public, Scientific, Principal Investigator
University of Bristol
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
0000-0001-8318-8907 | |
Phone | +44 117 455 4502 |
chris.metcalfe@bristol.ac.uk |
Study information
Study design | Pragmatic multicentre interventional randomized controlled trial (RCT) with qualitative component |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | ROMIO: Randomised Oesophagectomy - Minimally Invasive or Open |
Study acronym | ROMIO |
Study objectives | Laparoscopically-assisted oesophagectomy (LAO) is superior compared to standard open oesophagectomy (OO) with respect to recovery from surgery. |
Ethics approval(s) | South West Frenchay Research Ethics Committee, 11/05/2016, ref: 16/SW/0098 |
Health condition(s) or problem(s) studied | Oesophageal cancer |
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 | Procedure/Surgery |
Primary outcome measure | 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 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 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 |
Overall study start date | 01/12/2015 |
Completion date | 31/08/2021 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 446; UK Sample Size: 446 |
Total final enrolment | 363 |
Key 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 |
Key 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 |
Date of first enrolment | 01/06/2016 |
Date of final enrolment | 21/08/2019 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Bristol
BS2 8HW
United Kingdom
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
GI Surgery
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Chief Executive's Office
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
Stott Lane
Salford
M6 8HD
United Kingdom
City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Combe Park
Bath
BA1 3NG
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Level 3 Education & Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
https://ror.org/04nm1cv11 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | 01/04/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
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 plan | 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. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | quality assurance protocol | 01/03/2019 | 30/03/2020 | Yes | No |
Protocol article | protocol | 19/11/2019 | 27/10/2020 | Yes | No |
HRA research summary | 28/06/2023 | No | No | ||
Statistical Analysis Plan | version 1 | 12/09/2019 | 02/01/2024 | No | No |
Statistical Analysis Plan | version 1 | 12/09/2019 | 02/01/2024 | No | No |
Plain English results | 25/03/2024 | No | Yes | ||
Results article | 02/03/2024 | 26/03/2024 | Yes | No |
Additional files
Editorial Notes
26/03/2024: Publication reference added.
25/03/2024: A link to plain English results on CRUK was added.
02/01/2024: The following changes have been made:
1. A statistical analysis plan (SAP) has been uploaded and linked.
2. The previous public contact has been removed and a new principal investigator/scientific contact/public contact has been added.
3. The IRAS number has been added.
4. The intention to publish date has been changed from 01/04/2023 to 01/04/2024.
03/12/2021: The following changes have been made:
1. The study design has been changed from "Both; Both; Design type: Treatment, Surgery, Qualitative" to "Pragmatic multicentre interventional randomised controlled trial (RCT) with qualitative component".
2. The overall trial end date has been changed from 01/04/2022 to 31/08/2021.
3. The trial website has been added.
4. Royal United Hospitals Bath has been added to the trial participating centres.
27/10/2020: Publication reference added.
30/03/2020: Publication reference added.
14/01/2020: The public contact has been changed.
18/10/2019: The following changes have been made:
1. The final enrolment number has been added.
2. The recruitment end date was changed from 30/09/2019 to 21/08/2019.
3. The overall trial end date has been changed from 30/05/2021 to 01/04/2022.
4. The intention to publish date has been changed from 30/05/2022 to 01/04/2023.
24/04/2019: The trial contact details have been updated.
02/04/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Upper GI; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs" to "Oesophageal cancer" following a request from the NIHR.
06/03/2019: The recruitment end date has been changed from 28/02/2019 to 30/09/2019.
20/12/2018: The recruitment end date has been changed from 01/12/2018 to 28/02/2019.
18/08/2017: Exclusion criteria and interventions updated, Nottingham City Hospital added as a trial participating centre, IPD sharing statement added.
19/12/2016: Cancer Help UK lay summary link added.