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21 March 2013
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| [ Print-friendly version ] |
| ROMIO feasibility: Randomised controlled trial of minimally invasive or open oesophagectomy |
| ISRCTN | ISRCTN59036820 |
| DOI | 10.1186/ISRCTN59036820 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | ROMIO feasibility: Randomised controlled trial of minimally invasive or open oesophagectomy |
| Scientific title | The ROMIO trial - Randomised Oesophagectomy: Minimally Invasive or Open, a feasibility study |
| Acronym | ROMIO |
| Serial number at source | HTA: 10/50/65 , 13859 |
| 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://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13859 More details can be found at: http://www.hta.ac.uk/2827 Project protocol can be found at: http://www.hta.ac.uk/protocols/201000500065.pdf |
| Lay summary | Lay summary under review with external organisation |
| Ethics approval | NRES Committee South West - Frenchay, 17th July 2012, ref: 12/SW/0161 |
| Study design | Randomised interventional trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Upper Gastro-Intestinal Cancer/ oesophageal cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 28/02/2013 |
| Anticipated end date | 31/03/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned Sample Size: 72; UK Sample Size: 72 |
| Interventions |
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) |
| Primary outcome measure(s) | Fatigue (MFI-20); Timepoint(s): 2, 6, 42, 90, 185 days |
| Secondary outcome measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment (HTA) (UK) ref: 10/50/65 |
| Trial website | |
| Publications | |
| Contact name | Dr Kerry Avery |
| Address |
School of Social and Community Medicine
Canynge Hall 39 Whatley Road |
| City/town | Bristol |
| Zip/Postcode | BS8 2PS |
| Country | United Kingdom |
| Kerry.Avery@bristol.ac.uk | |
| Sponsor | University of Bristol (UK) |
| Address |
Senate House
Tyndall Avenue |
| City/town | Bristol |
| Zip/Postcode | BS8 1TH |
| Country | United Kingdom |
| Sponsor website: | http://www.bris.ac.uk/ |
| Date applied | 21/02/2013 |
| Last edited | 08/03/2013 |
| Date ISRCTN assigned | 25/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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