Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment

NARecruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

September 10, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

December 30, 2028

Conditions
Gastroesophageal Reflux Disease
Interventions
PROCEDURE

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.

Trial Locations (1)

250000

RECRUITING

Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center, Jinan

All Listed Sponsors
collaborator

Shandong University

OTHER

lead

Qilu Hospital of Shandong University

OTHER