Condition category
Cancer
Date applied
21/02/2013
Date assigned
25/02/2013
Last edited
06/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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 surgeon’s 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 surgeon’s discretion. Complete gastric mobilisation will be performed based on the right gastroepiploic and right gastric arteries. Pyloroplasty, pyloromyotomy or no drainage is at the surgeon’s 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 measures

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

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

http://www.bris.ac.uk/

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24888266
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27373720

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

06/07/2016: Publication reference added.