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Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2025

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

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

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04243668 (ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY), which is not on this map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04243668 nacompletednot on this map

Endoscopic anti reflux mucosal ablation theraphy (arma) for the treatment of proton pump inhibitor dependent gastro esophagealreflux disease: open label single center observational study

TypeinterventionalSponsorAsian Institute of Gastroenterology, IndiaRan2019 to 2023Enrolled216ConditionsGERDArmsANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
3 · Its place in the literature

Who cites it

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

7 authors.

Krithi Krishna KoduriDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Neeraj SinglaDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Rajesh Goud MaragoniDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Nitin JagtapDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Aniruddha Pratap SinghDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Rakesh KalapalaDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India. drkalpala@gmail.com.ORCID 0000-0003-3203-7708
D Nageshwar ReddyDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesAnti-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.

methodsThis 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.

resultsTotal 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.

conclusionIn 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 registrationClinicalTrials.gov (NCT04243668).

Indexed as

Ablation TechniquesGastroesophageal RefluxAdultAgedEsophageal pH MonitoringFemaleHumansMaleMiddle AgedProspective StudiesProton Pump InhibitorsQuality of LifeSurveys and QuestionnairesTime FactorsTreatment OutcomeProton Pump InhibitorsAnti-refluxARMAGERDMucosal ablation

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.