Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial
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).
• 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.