Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD (APDG)
Gastroesophageal Reflux
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring anti reflux mucosal ablation, ARMA
Eligibility Criteria
Inclusion Criteria: PPI dependent GERD for at least 6 months Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% in pH metry while off PPI Exclusion of primary esophageal motility disorders by manometry Upper endoscopy with biopsy (Exclusion of eosinophilic esophagitis) Exclusion Criteria: Sliding hiatal hernia >3cm Los Angeles grade C/D esophagitis Primary esophageal motility disorders Grade IV Hill´s flap valve Pregnancy or planed pregnancy in the next 12 months Eosinophilic esophagitis Paraesophageal hernia Previous esophageal or gastric surgery Barretts esophagus Liver cirrhosis Varices Lack of consent ASA physical status >III
Sites / Locations
- II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität MünchenRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Anti reflux mucosal ablation (ARMA)
Sham procedure
Patients randomized into the intervention arm receive ARMA and a follow up control after 2, 4, 6 and 12 months. PPI treatment is stopped after 2 months until the end of the study or worsening of symptoms. Esophagogastroduodenoscopy, manometry and pH metry is performed after 4 months.
Patients randomized into the sham procedure arm receive a esophagogastroduodenoscopy in the same setting as if ARMA would be performed. Patients in the Control group receive follow up controls after 2 and 4 months and after unblinding after 4 months are allowed to perform a crossover to receive ARMA. PPI treatment is stopped 2 months after the initial sham procedure until the end of the study or worsening of symptoms. If the patients receive ARMA as a crossover reevaluation is performed 2, 4, 6 and 12 months after the actual ARMA procedure.