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Endoscopy 2021; 53(11): 1162-1168
DOI: 10.1055/a-1319-5550
Innovations and brief communications

Radiofrequency vapor ablation for Barrett’s esophagus: feasibility, safety and proof of concept in a stepwise study with in vitro, animal, and the first in-human application

Sanne N. van Munster
1   Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
2   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
,
Roos E. Pouw
1   Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
,
Virender K. Sharma
3   Arizona Centers for Digestive Health, Scottsdale, Arizona, USA
,
Sybren L. Meijer
4   Department of Pathology, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
,
Bas L. A. M. Weusten
1   Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
5   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
,
Jacques J. G. H. M. Bergman
2   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
› Author AffiliationsTrial Registration: Netherlands National Trial Register (www.trialregister.nl) Registration number (trial ID): NL7270 Type of study: Prospective feasibility study
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Abstract

Introduction The Radiofrequency Vapor Ablation (RFVA) System (AquaMedical, Inc., Santa Ana, CA) is a novel ablation system for eradication of Barrett’s esophagus, that generates vapor at 100 °C using an RF electrode located in the catheter tip. We performed in-vitro dosimetry studies and the first in-human feasibility study.

Methods The system includes an RFVA generator with syringe pump and a through-the-scope-catheter. The RFVA system was tested in-vitro (lean-beef and porcine study) and ablation depth was compared to focal RFA. Two doses were selected for further in-vivo testing in dysplatic BE patients. Repeat endoscopy with histology was performed after 8 weeks to assess squamous conversion.

Results In porcine, RFVA 3-seconds was comparable to RFA, whereas RFVA 5-seconds produced slightly deeper ablation. We selected a conservative 1-second and 3-seconds for human study. Fifty-three ablations were successfully applied in 15 patients with no adverse events. Follow-up endoscopy showed a median squamous conversion of 55 % (IQR 33 – 74) and 98 % (56 – 99) for 1 and 3-seconds, respectively.

Conclusions In this 3-phase study with lean-beef, porcine and the first in-human application, the RFVA system was feasible for esophageal ablation and successfully and safely converted targeted BE areas into squamous epithelium.

Appendix 1s, 2s, Table 1s, 2s, Fig. 1s–3s



Publication History

Received: 31 July 2020
Received: 20 November 2020

Accepted: 20 November 2020

Accepted Manuscript online:
20 November 2020

Article published online:
18 February 2021

© 2020. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 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
    CrossrefPubMedSearch in Google Scholar
  • 2 Phoa KN, van Vilsteren FG, Weusten BL. et al. Radiofrequency ablation vs endoscopic surveillance for patients with Barrett esophagus and low-grade dysplasia: a randomized clinical trial. JAMA 2014; 311: 1209-1217
    CrossrefPubMedSearch in Google Scholar
  • 3 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
    Thieme ConnectPubMedSearch in Google Scholar
  • 4 Shaheen NJ, Sharma P, Overholt BF. et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. NEJM 2009; 360: 2277-2288
    CrossrefPubMedSearch in Google Scholar
  • 5 Phoa KN, Pouw RE, van Vilsteren FG. et al. Remission of Barrett's esophagus with early neoplasia 5 years after radiofrequency ablation with endoscopic resection: a Netherlands cohort study. Gastroenterology 2013; 145: 96-104
    CrossrefPubMedSearch in Google Scholar
  • 6 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
    CrossrefPubMedSearch in Google Scholar
  • 7 McVary KT, Gange SN, Gittelman MC. et al. Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2016; 195: 1529-1538
    CrossrefPubMedSearch in Google Scholar
  • 8 Gompelmann D, Shah PL, Valipour A. et al. Bronchoscopic thermal vapor ablation: best practice recommendations from an expert panel on endoscopic lung volume reduction. Respiration 2018; 95: 392-400
    CrossrefPubMedSearch in Google Scholar
  • 9 Thurkow A, Van Baal M, Van Eijndhoven H. Final results of a multicenter trial of safety and effectiveness of endometrial ablation with the AEGEA vapor system for the treatment of menorrhagia. J Minim Invasive Gynecol 2015; 22 (Suppl. 06) S46
    CrossrefPubMedSearch in Google Scholar
  • 10 Sharma P, Dent J, Armstrong D. et al. The development and validation of an endoscopic grading system for Barrett's esophagus: the Prague C & M criteria. Gastroenterology 2006; 131: 1392-1399
    CrossrefPubMedSearch in Google Scholar
  • 11 Saunders M, Dische S, Barrett A. et al. Continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small-cell lung cancer: a randomised multicentre trial. CHART Steering Committee. Lancet 1997; 350: 161-165
    CrossrefPubMedSearch in Google Scholar
  • 12 Dunkin BJ, Martinez J, Bejarano PA. et al. Thin-layer ablation of human esophageal epithelium using a bipolar radiofrequency balloon device. Surg Endosc 2006; 20: 125-130
    CrossrefPubMedSearch in Google Scholar
  • 13 Fleischer DE, Sharma VK. Endoscopic ablation of Barrett's esophagus using the Halo system. Dig Dis 2008; 26: 280-284
    CrossrefPubMedSearch in Google Scholar
  • 14 DeMeester SR, Omar A, Bergman JJ. et al. Initial human experience with a novel through-the-scope cryoballoon device for mucosal ablation. Gastroenterology 2012; 142 (Suppl. 01) S1038
    CrossrefPubMedSearch in Google Scholar
  • 15 Herrero LA, van Vilsteren FG, Visser M. et al. Simultaneous use of endoscopic resection and radiofrequency ablation is not safe in an esophageal porcine model. Dis Esophagus 2015; 28: 25-31
    CrossrefPubMedSearch in Google Scholar
  • 16 van Vilsteren FG, 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
    Thieme ConnectPubMedSearch in Google Scholar