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
| Autor: | Bas L. Weusten, Sybren L. Meijer, Roos E. Pouw, Sanne N. van Munster, Virender K. Sharma, Jacques J. Bergman |
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| Přispěvatelé: | Gastroenterology and Hepatology, Pathology, Gastroenterology and hepatology, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Syringe driver
medicine.diagnostic_test business.industry medicine.medical_treatment Gastroenterology Human study First in human Ablation medicine.disease Endoscopy 03 medical and health sciences Catheter 0302 clinical medicine medicine.anatomical_structure 030220 oncology & carcinogenesis Barrett's esophagus medicine 030211 gastroenterology & hepatology Esophagus Nuclear medicine business |
| Zdroj: | Endoscopy, 53(11), 1162-1168. Georg Thieme Verlag van Munster, S N, Pouw, R E, Sharma, V K, Meijer, S L, Weusten, B L A M & Bergman, J J G H M 2021, ' 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 ', Endoscopy, vol. 53, no. 11, pp. 1162-1168 . https://doi.org/10.1055/a-1319-5550 |
| ISSN: | 0013-726X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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