Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
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
Qilu Hospital of Shandong University
74 participants
Sep 10, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- -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 Criteria13
- 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.
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Interventions
During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.
Locations(1)
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NCT06348420