Condition category
Cancer
Date applied
18/05/2016
Date assigned
31/05/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Dr Rachel Brierley

ORCID ID

Contact details

University of Bristol
Clinical Trials and Evaluation Unit Bristol
Bristol Royal Infirmary
Level 7
Queen’s Building
Marlborough Street
Bristol
BS2 8HW
United Kingdom

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

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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).

Intervention type

Other

Phase

Drug names

Primary outcome measures

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

Eligibility

Participant inclusion criteria

Participants may enter study if ALL of the following apply:
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 5cm 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

Participants may not enter study if ANY of the following apply
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
v
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

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust

Sponsor details

Research & Innovation
Level 3 Education & Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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 our methods, so enabling better understanding of our 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.

Intention to publish date

30/05/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.