WATS3D to detect oesophageal high grade dysplasia and adenocarcinoma
Research type
Research Study
Full title
Wide area transepithelial sample oesophageal biopsy combined with computer assisted 3-dimensional tissue analysis (WATS3D) for the detection of high grade esophageal dysplasia and adenocarcinoma: A multi-center prospective, randomised, tandem study
IRAS ID
226791
Contact name
Rehan Haidry
Contact email
Sponsor organisation
CDx Diagnostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Barretts oesophagus (BE) is a well recognised premalignant condition of the oesophagus. In time it demonstrates the potential to transform into abnormal tissue (dysplasia) and subsequently oesophageal cancer. Improvements in endoscopic therapy for dysplasia or early oesophageal cancer means there is now a real need to improve detection of these changes before they develop into more advanced cancer.
Currently patients with BE undergo regular endoscopic surveillance with targeted and random biopsies, in order to detect dysplastic changes histologically – this process is both burdensome for pathology departments and inconvenient for the patient. Dysplasia and early cancer can now be removed through minimally invasive procedures such as radiofrequency ablation (RFA) or endoscopic mucosal resection (EMR), thereby reducing the need for and attendant morbidity of major surgeries such as oesphagectomy.
This will be a multi-centre, prospective, randomised tandem study. We aim to evaluate wide area transepithelial sample oesophageal biopsy with 3-dimensional computer assisted tissue analysis (WATS3D), as a potential substitute for the random sampling method that is currently recommended as an adjunct to targeted biopsy. WATS3D uses a new brush system to sample cells from the oesophageal mucosa – penetrating a wider area to deeper levels than normal cytology brushes. The sterile brush system can be deployed through the normal working channel of the endoscope. These samples will then undergo advanced computer analysis which will identify them as normal, dysplastic or cancerous. Results will be checked by an expert pathologist.
All patients (previously known to have dysplasia) will undergo targeted biopsies of abnormal areas identified on endoscopy, followed by a six week healing period. They will then be randomised to receive random biopsies followed by the WATS3D procedure or vice-versa. We anticipate that a higher number of patients will be identified with WATS3D than those who undergo the random biopsies. This will demonstrate the utility of WATS3D as a potential alternative to the current random biopsy protocol.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1433
Date of REC Opinion
23 Oct 2017
REC opinion
Further Information Favourable Opinion