FOCAL CRYOBALLOON ABLATION WITH 8SEC DOSE HAS SIMILAR EFFICACY AS 10SEC FOR TREATMENT OF BARRETT’S ESOPHAGUS RELATED NEOPLASIA

Aims Focal cryoballoon ablation (FCBA) is currently investigated for treatment of Barrett’s esophagus (BE) related neoplasia in a European multicenter study (Euro-Coldplay; NTR NL7253). After inclusion of 28/107 patients, the initial dose of 10sec was lowered to 8sec. In this current study, we compared the efficacy and safety of single FCBA treatment with 10sec versus 8sec in patients with limited BE (C≤2/M≤5).

Methods All 28 patients treated with 10sec were compared with the first 28 patients treated with 8sec. Treatments were performed by trained endoscopists in 7 Barrett referral centers. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy after a single FCBA, three expert adjudicators, blinded for treating physician and dosages, compared pre- and post-treatment images. Outcomes included median BE surface regression and stricture rate.

Results We included 56 patients (10sec n=28, 8sec n=28) with a median BE of C0M2 and comparable baseline characteristics. FCBA was technically successful in 27/28 (96%) patients for both cohorts. The median BE surface regression was comparable for 10sec and 8sec (80% [95%CI 75-90] and 80% [95%CI 66-90], respectively; p=0.65). Strictures requiring dilation were seen in 19% [95%CI 4-33] and 15% [95%CI 4-30] of the 10sec and 8sec group respectively (p=1.00). Two patients among the 10sec group developed a severe stricture requiring>3 dilations.

Table 1 Per-protocol analysis of primary outcomes after single FCBA treatment.

	10sec (n=27)	8sec (n=27)	P-value [1]
Median BE surface regression [2],% (p25-p75)	80 (75-92)	80 (59–92)	0.65
Stricture requiring dilation, n (%)	5 (19)	4 (15)	1.00
Severe stricture requiring>3 dilations, n (%)	2 (7)	0 (0)	0.44
Number of dilations, median (range)	1 (1-8)	2 (1-3)	0.78

¹For Mann-Whitney U test, Chi-squared test or Fisher’s exact test.

²Not assessable in one patient (8sec) due to missing pre-treatment images.

Conclusions In limited BE, single-session FCBA with 8sec has shown similar efficacy as compared to 10sec, and may theoretically result in less and less severe strictures. Therefore, further study into using 8sec dosing is recommended.

Publication History

Article published online:
14 April 2022