769. CLINICAL EVALUATION OF CRYOBALLOON ABLATION FOR BARRETTS OESOPHAGUS: A UK FIRST MULTI-CENTRE EXPERIENCE

Abstract

Abstract Introduction The Cryoballoon Focal Ablation System (CbFAS) (Pentax Medical Inc) is an innovative device designed for the endoscopic ablation of Barrett's-related neoplasia. This system has been shown to provide advantages such as reduced stricture rates and improved patient tolerance compared to the conventional standard of care, radiofrequency ablation (RFA). We report early outcomes from a prospective UK first multi-centre registry of consecutive patients who underwent Cryoablation for the endoscopic eradication (EET) of Barrett’s-related neoplasia. Methods Patients were prospectively enrolled from two tertiary referral centres for Barrett’s Oesophagus (BE). Inclusion criteria included patients with a BE segment no longer than 5cm with histologically-proven dysplasia on biopsy or endoscopic resection specimens suitable for EET of BE after MDT review. Cryoablation sessions were conducted at 3-month intervals until endoscopic eradication was complete. The standardised protocol involved administering 8 seconds per ablation for all enrolled patients with the CbFAS. Our primary outcome was complete eradication of BE. Secondary outcomes included the number of ablations performed, adverse events, device malfunction, stricture rate, patient tolerance, and endoscopist satisfaction which was evaluated using a 10-point Likert scale (1=poor, 10=excellent). Results Between January 2020 and December 2023, a total of 16 patients (35 treatment sessions) were treated. The median BE length was C0M2. Complete eradication of BE was achieved in 89% (8/9) of patients who had completed treatment. No instances of device malfunction or intraoperative adverse events were recorded. A stricture rate of 12.5% (2/16) was observed, both of which were successfully managed through endoscopic dilatation. All patients were recorded as tolerating the procedure well with sedation. The median endoscopist satisfaction score was 9 (+/- 2.4) with only one recorded instance of difficulty attributed to balloon positioning. Conclusions These preliminary results from the UK cryoablation registry suggest that cryoablation with the CbFAS is a safe and effective therapy for BE-related dysplasia. The stricture rate appears to be comparable to that observed with RFA and similar studies. With the planned enrolment of further centres and suitable patients, this registry will further enhance our understanding of the long-term efficacy and safety profile of cryoablation using the CbFAS.