A a uk first multi-centre experience evaluating cryoballoon ablation for barretts oesophagus

Aims Barretts Esophagus (BE) is a precancerous condition that effects between 1-2% of the general population. A number of ablative modalities have been developed to treat intestinal metaplasia and prevent progression of BE to cancer. The Cryoballoon Focal Ablation System (CbFAS) (Pentax Medical) 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 present a prospective UK multi-centre registry of consecutive patients who underwent cryoablation with the cbFAS for the endoscopic eradication (EET) of Barrett’s related neoplasia.

Methods Cryoablation was performed at two tertiary referral centres and data inputted into a national registry. Data was collected between January 2020 and December 2023. Only short segment BE less than 5cm were included in the study. Cryoablation sessions were conducted at a minimum of 3-month intervals until endoscopic eradication was complete. The primary outcomes of the study were complete histological eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D). Secondary outcomes included the number of ablations performed, adverse events, device malfunction, stricture rate, patient tolerance, and endoscopist satisfaction score which was evaluated using a 10-point Likert scale (1=poor, 10=excellent).

Results A total of 16 patients were treated, with a total of 35 ablations. The median BE length was reported as C0M2. CE-IM was achieved in 89% (8/9) of patients who had completed treatment on a per intention to treat analysis. CE-D was achieved in 100% of patients (9/9) who had completed treatment on a per intention to treat analysis. 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 (SD=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.

Publication History

Article published online:
27 March 2025