Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD (APDG)

Technical University of Munich

Status: Enrolling

Conditions: Gastroesophageal Reflux

Treatments: Procedure: Sham procedure; Procedure: Anti reflux mucosal ablation (ARMA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05763485

R0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Anti reflux mucosal ablation (ARMA)

Active Comparator group

Description:

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.

Treatment:

Procedure: Anti reflux mucosal ablation (ARMA)

Sham procedure

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham procedure