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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Vonoprazan
Druga potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
Esomeprazole 40mg
DrugIt 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)
Treatment groups
Trial outcomes
Primary outcomes
• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).
This can be find during endoscopy test
Secondary outcomes
• Improvement in GERD-Q scores at 8 weeks
GERD questionnaire can be calculated based on heart burn , regurgitation symptom scores which is scaled like 1 is very low symptoms, 5 is worse symptoms (outcome)
Sponsors and contacts
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