Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD
- Conditions
- Gastroesophageal Reflux
- Interventions
- Procedure: Anti reflux mucosal ablation (ARMA)Procedure: Sham procedure
- Registration Number
- NCT05763485
- Lead Sponsor
- Technical University of Munich
- Brief Summary
This is a prospective, randomized, single-blinded, interventional, controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation (ARMA) in PPI dependent gastroesophageal reflux disease (GERD) in comparison to controls with a sham procedure.
- Detailed Description
Patients who fulfill the inclusion criteria and, after informed consent, are willing to participate in this study will be prepared for ARMA. After sedation the patients will be randomized equally into an intervention and control Group. The patients are blinded to the procedure. The Patients in the intervention group receive ARMA using argon plasma coagulation (APC) at the gastroesophageal junction (EGJ) in two semicircular patterns while the control group receives a sham procedure. The approximate duration of the procedure is 30min. After the procedure the patients receive follow up controls at 2, 4, 6 and 12 months. During the first follow up, 2 months after the procedure symptoms are evaluated by questionnaires (GERD- HRQL, FSSG, VAG). Subsequently the PPI- medication is stopped in all patients until the end of the study or worsening of symptoms. During the second follow up 4 months after the initial procedure the symptoms are reevaluated by questionnaires. The patients are then unblinded and are told if they received ARMA or sham procedure. Those patients who received ARMA are examined by esophagogastroduodenoscopy, esophageal manometry and pH metry. Further assessments is performed by questionnaires 6 and 12 months after the initial procedure.
Those patients in the control group are allowed to take part in a crossover to receive the ARMA procedure as well. If they receive ARMA, symptoms are reevaluated 2 months after the procedure by questionnaires, esophagogastroduodenoscopy, esophageal manometry and pH metry. Further controls are performed after 4, 6 and 12 months by questionnaires.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Anti reflux mucosal ablation (ARMA) Anti reflux mucosal ablation (ARMA) 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. Sham procedure Sham procedure 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.
- Primary Outcome Measures
Name Time Method Improvement in symptoms of gastro esophageal reflux disease 4 months Improvement in symptoms of gastro esophageal reflux disease by more than 50% from baseline in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 4 months after procedure. Total score 0-50; higher scores indicate greater complaints.
- Secondary Outcome Measures
Name Time Method Change in symptoms of gastro esophageal reflux disease 12 months Change in symptoms of gastro esophageal reflux disease in visual analog scale (VAS) at 4, 6 and 12 months. Total score 0-10; higher scores indicate greater complaints.
PPI dependency 12 months Requirement and dose of PPI at 4, 6 and 12 months
Change in esophageal acid exposure at 4 months after ARMA 4 months after ARMA Change in esophageal acid exposure in pH metry 4 months after ARMA
Changes in cardia morphology 4 months after ARMA Changes in Hill's flap grade
Technical success rate 1 day Successful completion of ARMA
Change in lower esophageal sphincter pressure 4 months after ARMA 4 months after ARMA Change in lower esophageal sphincter pressure in manometry 4 months after ARMA
Postinterventional pain 1day Recording of postinterventional pain in visual analog scale (VAS). Higher scores indicate greater complaints.
Complication rate 12 months Recording of all complications in relation to the ARMA- procedure
Trial Locations
- Locations (1)
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
🇩🇪Munich, Bayern, Germany