Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Mar 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Anti-reflux mucosal valvuloplasty (ARMV) for patients suffering from gastroesophageal reflux disease (GERD). GERD is a condition where stomach acid frequently flows back into the esophagus, causing discomfort and other symptoms. The study compares the effectiveness and safety of ARMV to the traditional treatment, which involves taking daily Proton Pump Inhibitors (PPIs) that reduce stomach acid. Researchers hope to find out if ARMV can help patients who continue to have GERD symptoms even while taking PPIs.

To be eligible for the trial, participants need to be between 18 and 60 years old and have specific types of hiatal hernias and GERD symptoms that haven't improved with PPIs. Candidates should also have certain grades of esophagitis, which is inflammation of the esophagus. Those interested in participating will undergo tests to confirm their condition and will need to sign an informed consent form. If they qualify and decide to join, participants can expect to receive either the new treatment or continue with their current medication while being monitored for safety and effectiveness. This trial is currently recruiting, and it's open to individuals of any gender.

Gender

ALL

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 esophageal or gastric surgery, including ARMS or ARMA;
• • Uncontrolled systemic diseases;
• • Gastric outlet obstruction;
• • Pregnancy or planning to become pregnant.