Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kerry Avery
ORCID ID
Contact details
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
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Kerry.Avery@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 10/50/65, 13859
Study information
Scientific title
The ROMIO trial - Randomised Oesophagectomy: Minimally Invasive or Open, a feasibility study
Acronym
ROMIO
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
NRES Committee South West - Frenchay, 17/07/2012, ref: 12/SW/0161
Study design
Randomised interventional trial
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 below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
28/02/2013
Overall trial end date
31/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 72; UK Sample Size: 72
Participant 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
Recruitment start date
28/02/2013
Recruitment end date
31/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Social and Community Medicine
Bristol
BS8 2PS
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24888266
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27373720
Publication citations
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Protocol
Avery KN, Metcalfe C, Berrisford R, Barham CP, Donovan JL, Elliott J, Falk SJ, Goldin R, Hanna G, Hollowood AA, Krysztopik R, Noble S, Sanders G, Streets CG, Titcomb DR, Wheatley T, Blazeby JM, The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial., Trials, 2014, 15, 200, doi: 10.1186/1745-6215-15-200.
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Results
Metcalfe C, Avery K, Berrisford R, Barham P, Noble SM, Fernandez AM, Hanna G, Goldin R, Elliott J, Wheatley T, Sanders G, Hollowood A, Falk S, Titcomb D, Streets C, Donovan JL, Blazeby JM, Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial, Health Technol Assess, 2016 , 20, 48, 1-68, doi: 10.3310/hta20480.