THE NOVEL SWIPE CRYOBALLOON ABLATION DEVICE FOR TREATING LARGER AREAS OF BARRETT'S ESOPHAGUS: A MULTICENTER STUDY TO EVALUATE SAFETY AND DOSE-RESPONSE

Background:

Cryoballoon ablation (CBA) has been gaining attention as therapy for Barrett's esophagus (BE). CBA preserves the extracellular matrix and might therefore result in improved tolerability and lower stricture-rates when compared to other therapies. It comprises a through-the-scope system with a conformable balloon, that is simultaneously inflated and cooled using nitrous-oxide. Focal CBA has shown promising results, but is only suitable for limited BE. The 90 °-Swipe system (90 °-SCBA) has been developed to ablate 25% of the circumference over 3 cm in a single-step process.

We aimed to assess feasibility, safety and efficacy of 90 °-SCBA at increasing doses.

Methods:

Patients with flat BE, maximum circumferential extent 3 cm, containing low/high-grade dysplasia (LGD/HGD) or residual BE after endoscopic resection, were included in 5 centers.

We started with 0.8 mm/s (dose 1) and escalated with 0.1 mm/s until the optimal dose (OD) was found. OD was the lowest dose resulting in median BE-regression≥80% in absence of dose-related serious adverse events (DR-SAEs; severe pain (VAS> 6) ≥7 days or severe stenosis). BE-regression at 8 weeks follow-up endoscopy was assessed by 2 independent endoscopists by systematic comparison of baseline and follow-up images.

Results:

We included 13 patients, of which 12 (92%) had technically successful ablation in median 12 minutes. Device malfunction occurred in 2 patients (16%). No SAEs occurred. BE-regression at follow-up was 78% (IQR 68 – 86) with dose 1 and 85% (75 – 95) with dose 2, which was thus defined as OD. Median pain scores were 4 (3 – 6), 1 (0 – 2) and 0 (0 – 1) at days 0,1,7 respectively.

Tab. 1:

Baseline characteristics

	Dose 1 (0.8 mm/second); N = 6	Dose 2 (0.7 mm/second); N = 7
Worst pathology prior to first treatment, n (%)	LGD 6 (100)	LGD 4 (57) – HGD/cancer 3 (43)
Previous endoscopic resection, n (%)	1 (17)	3 (43)
Maximum BE extent prior to inclusion, cm	3 (IQR 2 – 3)	4 (IQR 2 – 5)

Conclusion:

Our multicenter study shows that 90 °-SCBA is feasible and safe. The optimal dose (0.7 mm/s) results in 85% BE-regression. This will be confirmed in a consecutive study.