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Novel cryoballoon 180° ablation system for treatment of Barrett’s esophagus-related neoplasia: a first-in-human studyTrial Registration: Netherlands National Trial Register (www.trialregister.nl)Registration number (trial ID): NL6495 Type of study: Prospective, single-arm, multi-center study
Background The novel 180° cryoballoon (CbAS180) enables semicircumferential treatment over a length of 3 cm per application. This first-in-human study evaluates its feasibility, efficacy, and safety for the treatment of Barrett’s esophagus (BE) neoplasia.
Methods This multicenter study consisted of dose-finding and extension phases. Dose-finding started with the lowest dose possible (1.0 mm/s). For each dose, six patients were treated circumferentially over a 3-cm length. The dose was increased until the median BE regression was ≥ 60 % without serious adverse events (SAEs). In the extension phase, the dose was confirmed in 19 new patients. The outcomes were technical success, BE regression after one treatment, and SAEs.
Results 25 patients (median Prague C0M3) were included (6 dose-finding/19 extension). In two patients, the CbAS180 could not be applied because of unstable balloon positioning. The technical success rate was 96 % (22 /23). In the six dose-finding patients, the starting dose resulted in median BE regression of 94 % (95 % confidence interval [CI] 60 %–97 %) without SAEs and was thus considered effective. Overall median BE regression was 80 % (95 %CI 60 %–90 %).
Conclusion Single-session CbAS180 seems feasible, safe, and effective, and is a promising technique for the treatment of patients with BE neoplasia.
Received: 30 September 2020
Accepted after revision: 19 January 2021
04 March 2021 (online)
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- 1 Weusten B, Bisschops R, Coron E. et al. Endoscopic management of Barrett’s esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2017; 49: 191-198
- 2 Fitzgerald RC, di Pietro M, Ragunath K. et al. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett’s oesophagus. Gut 2014; 63: 7-42
- 3 Shaheen NJ, Falk GW, Iyer PG. et al. ACG Clinical Guideline: Diagnosis and management of Barrett’s esophagus. Am J Gastroenterol 2016; 111: 30-50
- 4 van Munster SN, Overwater A, Haidry R. et al. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett’s esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc 2018; 88: 795-803.e2
- 5 Baust JG, Gage AA, Bjerklund Johansen TE. et al. Mechanisms of cryoablation: clinical consequences on malignant tumors. Cryobiology 2014; 68: 1-11
- 6 Baust JG, Gage AA. The molecular basis of cryosurgery. BJU Int 2005; 95: 1187-1191
- 7 Künzli H, Schölvinck D, Meijer S. et al. Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett’s esophagus islands. Endoscopy 2016; 49: 169-175
- 8 Canto MI, Shaheen NJ, Almario JA. et al. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus (with video). Gastrointest Endosc 2018; 88: 438-446.e2
- 9 van Munster SN, Overwater A, Raicu MGM. et al. A novel cryoballoon ablation system for eradication of dysplastic Barrett’s esophagus: a first-in-human feasibility study. Endoscopy 2020; 52: 193-201
- 10 Persson J, Engström C, Bergquist H. et al. Validation of instruments for the assessment of dysphagia due to malignancy of the esophagus. Dis Esophagus 2019; 32: doy125
- 11 Ogilvie AL, Dronfield MW, Ferguson R. et al. Palliative intubation of oesophagogastric neoplasms at fibreoptic endoscopy. Gut 1982; 23: 1060-1067
- 12 van Vilsteren FGI, Alvarez Herrero L, Pouw RE. et al. Predictive factors for initial treatment response after circumferential radiofrequency ablation for Barrett’s esophagus with early neoplasia: a prospective multicenter study. Endoscopy 2013; 45: 516-525
- 13 Belghazi K, Pouw R, Sondermeijer C. et al. A single-step sizing and radiofrequency ablation catheter for circumferential ablation of Barrett’s esophagus: Results of a pilot study. United Eur Gastroenterol J 2018; 6: 990-999
- 14 van Vilsteren FGI, Phoa KN, Alvarez Herrero L. et al. Circumferential balloon-based radiofrequency ablation of Barrett’s esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase. Clin Gastroenterol Hepatol 2013; 11: 491-498.e1
- 15 von Elm E, Altman DG, Egger M. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies. Int J Surg 2014; 12: 1495-1499
- 16 Trindade A, Canto M. Circumferential treatment of long-segment Barrett’s esophagus using the next-generation cryoballoon. Endoscopy 2019; 51: E69-E70
- 17 Qumseya BJ, Wani S, Desai M. et al. Adverse events after radiofrequency ablation in patients with Barrett’s esophagus: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2016; 14: 1086-1095.e6
- 18 Phoa KN, Pouw RE, Bisschops R. et al. Multimodality endoscopic eradication for neoplastic Barrett oesophagus: results of an European multicentre study (EURO-II). Gut 2016; 65: 555-562
- 19 Pouw RE, Visser M, Odze RD. et al. Pseudo-buried Barrett’s post radiofrequency ablation for Barrett’s esophagus, with or without prior endoscopic resection. Endoscopy 2014; 46: 105-109