Comparing Anti-reflux Mucosal Valvuloplasty to Proton Pump Inhibitors for Treating Gastroesophageal Reflux Disease in Adults Aged 18 to 60

What this Trial Is About

Researchers are evaluating the relative benefits, safety, and effectiveness of Anti-reflux mucosal valvuloplasty ARMV compared to daily Proton Pump Inhibitors PPIs in patients with Gastroesophageal Reflux Disease GERD. This trial aims to better understand how ARMV, a minimally invasive procedure, compares to standard PPI treatment in managing GERD symptoms and improving patients quality of life. The ARMV procedure is performed under general anesthesia, using an endoscope to release and reconstruct a segment of mucosa at the esophagogastric junction to form a mucosal flap. This flap is secured with metal clips to prevent flattening and promote reflux prevention. Patients continue PPI therapy for one month after ARMV to aid healing before stopping the medication. The comparison group continues PPI treatment with dosage adjustments based on symptom control. PPI use is carefully recorded in medication diaries. Participants will undergo endoscopic examination and various follow-up assessments including symptom questionnaires, esophageal pH monitoring, and endoscopic evaluations over up to three years. Key outcomes include GERD-related quality of life, reflux scores, esophagitis presence, mucosal flap appearance, PPI usage, and adverse events. Researchers will closely monitor participants symptoms, medication use, and safety throughout the study period, which lasts until December 2028.

Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment