RecruitingNot ApplicableNCT06955520

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Sponsor

Asian Institute of Gastroenterology, India

Enrollment

300 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

GERD

Summary

Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis. Primary Objective: • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg. Secondary Objectives * To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events in each treatment group.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Age ≥18 years
History of POEM for achalasia
Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM
GERD symptoms (heartburn, regurgitation) for ≥4 weeks
Willingness to provide informed consent and comply with study procedures

Exclusion Criteria6

History of prior anti-reflux surgery
Presence of Barrett's esophagus, esophageal stricture, or malignancy
Severe gastroparesis or esophageal motility disorder unrelated to achalasia
Pregnancy or breastfeeding
Severe hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min)
Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal healing

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Interventions

DRUGVonoprazan

a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.

DRUGEsomeprazole 40mg

It is a proton pump inhibitor which reduces the excessive acid secretion in the stomach and it heals grade B esophagitis (\>5mm ulcer between two mucosal folds in esophagus)