Cryoablation (8 seconds) for the Management of Barrett’s Oesophagus
Research type
Research Study
Full title
Cryoablation (8 seconds) for the Management of Barrett’s Oesophagus (BE) in treatment naive patients
IRAS ID
223047
Contact name
Rehan Haidry
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Barrett’s Oesophagus (BE) is a pre-malignant condition with the potential to develop into oesophageal adenocarcinoma. Initially BE may transform from non-dysplastic intestinal metaplasia to low grade dysplasia, high grade dysplasia and early adenocarcinoma.
Once diagnosed with BE, patients enter a life-long surveillance program in order to detect early dysplasia and adenocarcinoma, so to stop progression to advanced disease.
Detection of dysplasia and early adenocarcinoma may allow endoscopic treatment, saving the patient from going through with extensive surgery such as oesophagectomy that has long complications and recovery period.
Advancement in endoscopic therapy has now allowed detection of early neoplastic lesions in the oesophagus and subsequently resection with EMR (endoscopic mucosal resection); However, metachronous lesions develop in up to 30 % of patients, and therefore a two-step approach involving the removal of all visible neoplasia followed by ablation of the remaining Barrett’s mucosa is required. Ablative therapy can also be used without EMR in cases of flat dysplasia. The most common form of ablative therapy is Radiofrequency ablation RFA. This technique utilizes heat to destroy dysplastic cells. It has high success rates (66-100%), but this is not free of risks and side effects (e.g. bleeding, perforation, stricture, and pain).
The Focal Cryoballoon Ablation System (Cold therapy) is an alternative option to RFA (heat therapy). It uses a combination of an inflatable balloon passed through the accessory channel of the endoscope and applies liquid nitrous oxide. The Cryoballoon Focal Ablation system is CE-marked (September 2015) and has been cleared by the U.S. Food and Drug Administration under K131523.
This project will use Cryoablation instead of RFA, in post EMR patients or in those with flat dysplasia. Other aspect of patient's management or frequency of care will not change.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
17/LO/1000
Date of REC Opinion
5 Jul 2017
REC opinion
Unfavourable Opinion