Comparing Routine Versus Symptom-Based Protein Pump Inhibitor Use to Prevent Acid Reflux After Per Oral Endoscopic Myotomy in Esophageal Achalasia

What this Trial Is About

Researchers are evaluating the use of protein pump inhibitors PPIs to prevent gastroesophageal reflux after Per Oral Endoscopic Myotomy POEM, a treatment for esophageal achalasia. This condition affects the esophagus and POEM is known for its safety and effectiveness, but many patients experience acid reflux afterward. The study aims to compare routine PPI use for 12 months versus prescribing PPIs only when symptoms appear to see which approach better reduces acid reflux. Participants will be randomly assigned to one of two groups one receiving lansoprazole 30mg once daily as a systematic PPI therapy for 12 months, and the other receiving PPI therapy only as needed based on symptoms. This is an open-label trial, meaning both participants and researchers know the treatment group. The study will monitor participants over a year to observe differences in acid reflux and other health outcomes. Throughout the study, participants will have assessments at various time points to measure the presence of acid reflux, quality of life, symptom severity, and treatment tolerance. The primary outcome is the presence of pathological acid reflux at 6 months, with secondary outcomes including quality of life and symptom measures at weeks 6, 6 months, and 12 months. The trial will also track the amount of PPI used and evaluate safety and tolerability over the year-long follow-up.

Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia