Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Trial Parameters
Brief Summary
The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
Eligibility Criteria
Inclusion Criteria: * 18-60 years of age; * Hiatal hernia ≤ 2 cm; * Sliding hernia ≤ 2 cm; * Recurrence of GERD symptoms after cessation of PPIs; * On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks; * Esophagitis (Los Angeles Classification) Grade B, C, or D; * Hill's flap valve grade ≤ III; * Observation of distal esophageal pH \< 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%; * Normal or near-normal esophageal motility; * Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg; * DeMeester score ≥ 14.7 or total reflux episodes exceeding 73; * Completion of a signed informed consent form. Exclusion Criteria: * BMI \> 35 kg/m2; * ASA \> II; * Barrett's esophagus; * Hiatal hernia \> 2 cm; * Esophagitis (Los Angeles Classification) Grade A or No esophagitis； * Hill's flap valve grade \> III； * Peptic ulcer disease; * Primary esophageal motility disorders such as achalasia; * Severe gastroparesis; * History of previous esophagea