ROMIO: Randomised Oesophagectomy - Minimally Invasive or Open

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 363 人开始时间: 2016年5月31日最近更新: 2024年4月8日

适应症

试验速览

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30826769 quality assurance protocol (added 30/03/2020) 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31748296/ protocol (added 27/10/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38525931/ (added 26/03/2024)

•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 5 cm 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

•Current exclusion criteria as of 18/08/2017:
•1. Patients with high grade dysplasia (squamous cell or adenocarcinoma)
•2. Patients with T4b, or any stage with M1
•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
•Previous exclusion criteria:
•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

发起方

niversity Hospitals Bristol NHS Foundation Trust