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DOI: 10.1055/a-2531-8227
Efficacy and safety of H-APC in Barrett's esophagus: Italian prospective multicenter study
Clinical Trial: Registration number (trial ID): NCT05645679, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective Multi Center Study
Abstract
Background and study aims
Hybrid argon plasma coagulation (H-APC) is a novel technique for ablation of neoplastic Barrett's esophagus (BE), consisting in submucosal fluid injection and subsequent APC of visible BE. The aim of this study was to assess H-APC efficacy, safety, and tolerability.
Patients and methods
We prospectively included patients undergoing H-APC ablation at four Italian Hospitals from September 2022 to March 2024. Patients with BE C3M5 maximum extent, low- or high-grade dysplasia (LGD, HGD) or residual BE after endoscopic resection (ER) of visible lesions were included. Patients who had undergone previous ablative treatments were excluded. The primary endpoints were complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D). Secondary endpoints were safety in terms of major and minor adverse events (AEs) and tolerability, assessed using pain (0–10) and dysphagia (0–5) scores within 7 days post-ablation (NCT05645679).
Results
Among the 51 enrolled patients (mean circumferential 0.43 cm; standard deviation [SD] 0.72, mean maximum longitudinal 2.20 cm; SD 1.09) who completed treatment (80 H-APC sessions), 45.1% (23/51) had prior ER of visible lesions. All patients achieved both CE-IM and CE-D (51/51), requiring a mean of 1.51 sessions (SD 0.83). Only one case of fever and absolute dysphagia was observed (1/51; 1.96% AEs). Regarding tolerability, mean pain score was 1.3 (SD 1.99) whereas mean dysphagia score was 1.28 (SD 0.56).
Conclusions
The H-APC technique showed promising results in terms of effectiveness and safety with good tolerability in achieving initial CE-IM and CE-D in a selected population of BE patients.
Keywords
Endoscopy Upper GI Tract - RFA and ablative methods - Barrett's and adenocarcinoma - Reflux diseasePublication History
Received: 09 October 2024
Accepted after revision: 16 December 2024
Accepted Manuscript online:
03 February 2025
Article published online:
26 February 2025
© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Davide Massimi, Roberta Maselli, Silvia Pecere, Cristiano Spada, Gianluca Andrisani, Francesco Maria Di Matteo, Antonella La Terra, Franco Coppola, Antonio Capogreco, Roberto De Sire, Ludovico Alfarone, Maddalena Menini, Marco Spadaccini, Cesare Hassan, Alessandro Repici. Efficacy and safety of H-APC in Barrett's esophagus: Italian prospective multicenter study. Endosc Int Open 2025; 13: a25318227.
DOI: 10.1055/a-2531-8227
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