Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months.

IF 2.1 Q3 GASTROENTEROLOGY & HEPATOLOGY

Indian Journal of Gastroenterology Pub Date : 2025-06-11 DOI:10.1007/s12664-025-01761-z

Krithi Krishna Koduri, Neeraj Singla, Rajesh Goud Maragoni, Nitin Jagtap, Aniruddha Pratap Singh, Rakesh Kalapala, D Nageshwar Reddy

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引用次数: 0

Abstract

Background and objectives: Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12 months.

Methods: This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] > 6% or AET > 4.2% with reflux episodes > 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three months and 12 months, with 24-h-pH-impedance monitoring at baseline and 12 months.

Results: Total 216 patients (67.1% males, mean age = 38.7 years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill's grade I and 93 (43.1%) had Hill's grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA) grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three months and to 8.3 (12.3) at 12 months (p = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three months and 3.9 (6.9) and 3.9 (6.9) at 12 months, respectively (p = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (n = 125, p = 0.009) at 12 months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (p = 0.001). There was also a significant decrease in number of patients with AET 4% to 6% and > 6% and reflux episodes 40-80 and > 80 and DeMeester score > 14.72, as well as an increase in patients with AET < 4% and reflux episodes < 40. There was a significant improvement in Hill's grading and endoscopic esophagitis at one year. No major adverse events were observed.

Conclusion: In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12 months. This procedure is relatively simple, widely accessible and has a good safety profile.

Clinical trial registration: ClinicalTrials.gov (NCT04243668).

查看原文本刊更多论文

抗反流黏膜消融治疗12个月的疗效和安全性。

背景和目的：抗反流粘膜消融（ARMA）是质子泵抑制剂（PPI）控制胃食管反流病（GERD）患者的一种微创治疗方法。本研究在12个月内评估了ARMA的安全性和有效性。方法：这项单中心前瞻性研究纳入了ppi依赖性GERD患者（酸暴露时间[AET] bbbb6 %或AET b> % 2%， 24小时ph -阻抗监测时反流发作bbbb8 %）。ARMA采用标准化的混合技术（粘膜下提升后消融）进行。在基线、3个月和12个月时使用GERD健康相关生活质量问卷（HRQL）对患者进行评估，并在基线和12个月时进行24小时ph阻抗监测。结果：216例患者行ARMA手术，其中男性67.1%，平均年龄38.7岁。在基线时，123例（56.9%）患者为Hill's I级，93例（43.1%）患者为Hill's II级。90例（41.7%）患者为洛杉矶（LA） A级，2例（0.93%）患者为LA b级。GERD-HRQL评分从基线时的43.8（12.6）显著改善到3个月时的20.6（13.8）和12个月时的8.3 (12.3)（p = 0.001）。平均（SD）胃灼热和反流评分分别从基线时的22.9（10.8）和20.6（9.4）改善到3个月时的11.1（8.7）和9.5(8.7)，12个月时的3.9（6.9）和3.9 (6.9)（p = 0.001）。12个月时，AET（中位数[IQR]）从11.9（15.9）降至7.6 (10.8)(n = 125, p = 0.009)， DeMeester评分中位数从42.4（47.1）降至26.2 (32.3)（p = 0.001）。AET患者的数量也显著减少了4%至6%，>减少了6%，反流发作40-80和> 80，DeMeester评分> 14.72，以及AET患者的数量增加。结论：在ppi依赖性GERD患者中，ARMA导致持续的症状减轻和12个月时生活质量的改善。该程序相对简单，可广泛使用并且具有良好的安全性。临床试验注册：ClinicalTrials.gov （NCT04243668）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Indian Journal of Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

3.90

自引率

10.00%

发文量

期刊介绍： The Indian Journal of Gastroenterology aims to help doctors everywhere practise better medicine and to influence the debate on gastroenterology. To achieve these aims, we publish original scientific studies, state-of -the-art special articles, reports and papers commenting on the clinical, scientific and public health factors affecting aspects of gastroenterology. We shall be delighted to receive articles for publication in all of these categories and letters commenting on the contents of the Journal or on issues of interest to our readers.