Efficacy and safety of H-APC in Barrett's esophagus: Italian prospective multicenter study.

IF 2.3 Q3 GASTROENTEROLOGY & HEPATOLOGY Endoscopy International Open Pub Date : 2025-02-26 eCollection Date: 2025-01-01 DOI:10.1055/a-2531-8227
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
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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.

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H-APC治疗Barrett食管的疗效和安全性:意大利前瞻性多中心研究。
背景和研究目的:混合氩等离子体凝固(H-APC)是一种用于肿瘤性巴雷特食管(BE)消融的新技术,包括粘膜下液注射和随后可见BE的APC。本研究的目的是评估H-APC的疗效、安全性和耐受性。患者和方法:我们前瞻性地纳入了2022年9月至2024年3月在意大利四家医院接受H-APC消融的患者。包括BE最大程度C3M5,低或高级别发育不良(LGD, HGD)或内镜下切除(ER)可见病变后残留BE的患者。既往接受过消融治疗的患者排除在外。主要终点是完全根除肠化生(CE-IM)和不典型增生(CE-D)。次要终点是主要和次要不良事件(ae)方面的安全性和耐受性,使用消融后7天内的疼痛(0-10)和吞咽困难(0-5)评分进行评估(NCT05645679)。结果:51例入组患者(平均周长0.43 cm;标准差[SD] 0.72,平均最大纵向2.20 cm;完成治疗(80 H-APC疗程)的患者SD 1.09, 45.1%(23/51)有明显病变的ER。所有患者均实现了CE-IM和CE-D(51/51),平均需要1.51个疗程(SD 0.83)。仅1例出现发热和绝对吞咽困难(1/51;1.96% AEs)。在耐受性方面,平均疼痛评分为1.3 (SD 1.99),平均吞咽困难评分为1.28 (SD 0.56)。结论:H-APC技术在有效性和安全性方面显示出良好的结果,在选定的BE患者群体中实现初始CE-IM和CE-D具有良好的耐受性。
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Endoscopy International Open
Endoscopy International Open GASTROENTEROLOGY & HEPATOLOGY-
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