Evaluation of a non-endoscopic immunocytological device (Cytosponge) for Barrett?s oEsophagus Screening Trial in a case control study: BEST 2

Overview

No summary available.

Registry

who.int

Start Date

August 5, 2011

End Date

TBD

Last Updated

8 years ago

Study Type

Observational

Sex

All

Sponsor

•1\. Any participant 18 years and above clinically fit for an endoscopy with Barrett?s oesophagus (Cases) with or without upper gastrintestinal (GI) symptoms
•2\. Any participant 18 years and above clinically fit for an endoscopy with upper GI symptoms of reflux or dyspepsia as an indication for endoscopy / gastroscopy (Controls)
•3\. Ability to provide informed consent
•4\. Patients who have undergone endoscopic mucosal resection (EMR) for high grade dysplasia and due for repeat endoscopy

•1\. Individuals with a diagnosis of an oro\-pharynx, oesophageal or gastro\-oesophageal tumour, or symptoms of dysphagia
•2\. Oesophageal varices, stricture or requiring dilatation of the oesophagus
•3\. On anticoagulation therapy / medication (warfarin, clopridogrel, heparin or tinzaparin)
•4\. Individuals who have had a myocardial infarction or any cardiac event less than six months ago
•5\. Individuals who have had a cerebrovascular event \< 6 months ago where their swallowing has been affected
•6\. Patients who have had previous treatment such as photodynamic therapy (PDT) or radio frequency ablation (RFA)
•7\. Participants who are unable to provide informed consent
•8\. Participants under age 18
•9\. Participants who exclude beef from their diet as the gelatine is beef based. This can be discussed with the patient
•10\. Endoscopy is generally avoided in pregnant women and therefore it is unlikely that any pregnant women will be included although pregnancy would not be an absolute contraindication. Pregnancy / pregnancy test will not be recorded as part of the trial