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Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Sponsor: Qilu Hospital of Shandong University
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2024-09-10
Completion Date
2028-12-30
Last Updated
2024-11-18
Healthy Volunteers
No
Conditions
Interventions
anti-reflux mucosal valvuloplasty (ARMV)
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)
Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center
Jinan, Shandong, China