About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vonoprazan
- Esomeprazole 40mg