ROMIO feasibility: Randomised controlled trial of minimally invasive or open oesophagectomy

ISRCTN	ISRCTN59036820
DOI	https://doi.org/10.1186/ISRCTN59036820
Secondary identifying numbers	HTA 10/50/65, 13859

Submission date: 21/02/2013
Registration date: 25/02/2013
Last edited: 07/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-comparing-different-types-surgery-treat-cancer-food-pipe-romio-pilot

Study website

Contact information

Prof Chris Metcalf
Scientific

Bristol Medical School: Population Health Sciences, University of Bristol
Bristol
BS8 2PS
United Kingdom

Email	chris.metcalfe@bristol.ac.uk

Study information

Study design	Randomised interventional trial
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 below to request a patient information sheet
Scientific title	The ROMIO trial - Randomised Oesophagectomy: Minimally Invasive or Open, a feasibility study
Study acronym	ROMIO
Study objectives	Current study hypothesis: Study hypothesis To compare, in patients with cancer of the oesophagus, the clinical and cost-effectiveness of minimally invasive and open surgical procedures in terms of recovery, health-related quality of life, cost and survival. At present, we are conducting a feasibility study, during which the methodology and infrastructure for the main trial will be established. The core of this preliminary work will be an assessment of the feasibility of comparing surgical procedures for oesophagectomy in a pilot two-centre randomised trial. Specific objectives include: 1. To pilot the randomisation process and investigate reasons for any difficulties in recruitment so that these are tackled before the main trial. 2. To establish the proportion of potentially eligible patients who can be recruited to the trial, and so inform the number of centres required in the main trial. 3. To develop manuals for the different surgical procedures. 4. To develop a manual for the pathological processing. 5. To consider the appropriate statistical model for estimating treatment effectiveness whilst allowing for clustering in the data due to between surgeon variation. 6. To develop and evaluate an acceptable method of keeping patients blind to their allocation in the week after surgery. 7. To establish outcome measures for the main trial which are recognised as a comprehensive, valid and reliable assessment of oesophagectomy outcome. Previous study hypothesis: To compare, in patients with cancer of the oesophagus, the clinical and cost-effectiveness of minimally invasive and open surgical procedures in terms of recovery, health-related quality of life, cost and survival. At present, we are conducting a feasibility study, during which the methodology and infrastructure for the main trial will be established. The core of this preliminary work will be an assessment of the feasibility of comparing surgical procedures for oesophagectomy in a pilot two-centre randomised trial. Specific objectives include: 1. To pilot the randomisation process and investigate reasons for any difficulties in recruitment so that these are tackled before the main trial. 2. To establish the proportion of potentially eligible patients who can be recruited to the trial, and so inform the number of centres required in the main trial. 3. To develop manuals for the different surgical procedures. 4. To develop a manual for the pathological processing. 5. To consider the appropriate statistical model for estimating treatment effectiveness whilst allowing for clustering in the data due to between surgeon variation. 6. To develop and evaluate an acceptable method of keeping patients blind to their allocation in the week after surgery. 7. To establish outcome measures for the main trial which are recognised as a comprehensive, valid and reliable assessment of oesophagectomy outcome. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/105065 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0011/81668/PRO-10-50-65.pdf
Ethics approval(s)	NRES Committee South West - Frenchay, 17/07/2012, ref: 12/SW/0161
Health condition(s) or problem(s) studied	Upper Gastro-Intestinal Cancer/oesophageal cancer
Intervention	Lap-assisted oesophagectomy, This operation will consist of identical steps as described above, but access to the abdominal cavity will be achieved with four or five 10 or 5mm incisions and surgery performed laparoscopically. Placement of a feeding jejunostomy is at the surgeons discretion and may be performed laparoscopically or by extending a port site to a 8cm abdominal incision. The thoracic part of the operation will be performed as described above. Open oesophagectomy, The operation consists of a two-phase oesophagectomy (abdomen and right chest) with a two-field lymphadenectomy (abdomen and thorax) and it will involve these key steps. Abdominal phase: The incision, (midline or subcostal) is at the surgeons discretion. Complete gastric mobilisation will be performed based on the right gastroepiploic and right gastric arteries. Pyloroplasty, pyloromyotomy or no drainage is at the surgeons discretion. Lymphadenectomies along the common hepatic artery. Totally minimally invasive oesophagectomy (MIO): This will consist of performing the steps of the abdominal and chest phases of the operation as described above, but using laparoscopic and thoracoscopic techniques for each phase respectively. It may be a 3 phase minimally invasive operation. And the anastomosis is performed with a left cervical incision. Follow Up Length: 6 month(s)
Intervention type	Procedure/Surgery
Primary outcome measure	Fatigue (MFI-20); Timepoint(s): 2, 6, 42, 90, 185 days
Secondary outcome measures	1. Bang Blinding Index; Timepoint(s): 2, 6 days 2. HRQL; Timepoint(s): Pre-surgery, 6, 42, 90, 185 days 3. Length of hospital stay; Timepoint(s): day 42 4. Pain; Timepoint(s): Pre-surgery, 2, 3, 6 days 5. Procedural outcome measures; Timepoint(s): Lymph node count, positive resection margins, duration of operation, blood loss - day 42 6. Resource use; Timepoint(s): 6, 42, 90, 185 days 7. Spirometry (lung function); Timepoint(s): Pre-surgery, 3, 6 days 8. Surgical morbidity (Accordian & Clavien-Dindo classifications); Timepoint(s): 2, 3, 6 days 9. Survival time; Timepoint(s): 6 months
Overall study start date	31/01/2013
Completion date	21/10/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 72; UK Sample Size: 72
Total final enrolment	273
Key inclusion criteria	1. Male or female patients 2. Over 18 years of age 3. Oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high grade dysplasia 4. Endoscopic evidence before treatment of a tumour starting more than 5cm below cricopharyngeus 5. Endoscopic evidence before treatment of a tumour involving less than 4 centimetres of the gastric wall 6. Final tumour stage between high grade dysplasia and T3N1M0 7. Referred for primary oesophagectomy or referred for oesophagectomy after neoadjuvant treatment 8. Able to provide written informed consent
Key exclusion criteria	1. Stage 4 disease 2. Type 3 tumours of the oesophagogastric junction 3. Localised squamous cell cancer who elect to undergo definitive chemoradiotherapy 4. High grade dysplasia who elect to undergo radiofrequency ablation or endoscopic mucosal resection 5. Evidence of previous complex thoracotomies or laparotomies 6. Evidence of previous/concomitant malignancy that would interfere with the study protocol 7. Pregnancy 8. Participating randomised trials that may interfere with this protocol
Date of first enrolment	08/04/2013
Date of final enrolment	21/10/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Bristol

Senate House, Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom

Website	http://www.bris.ac.uk/
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available on request from chris.metcalfe@bristol.ac.uk 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	protocol	02/06/2014		Yes	No
Results article	results	01/06/2016		Yes	No
Protocol article	quality assurance protocol	01/03/2019	30/03/2020	Yes	No

Editorial Notes

07/06/2024: The following changes were made:
1. The recruitment start date was changed from 28/02/2013 to 08/04/2013.
2. The recruitment end date was changed from 31/03/2013 to 21/10/2016.
3. The study hypothesis was updated.
4. The Study Centre was amended.
5. Study website added.
6. The overall study start date was changed from 28/02/2013 to 31/01/2013.
7. The overall study end date was changed from 31/03/2013 to 21/10/2016.
8. The study contact was updated.
9. Total final enrolment was added.
10. Individual participant data (IPD) sharing plan and summary added.
30/03/2020: Publication reference added.
06/07/2016: Publication reference added.