Clinical trial NCT05763485: Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD
Official title: Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD: a Prospective Randomized, Single-blinded, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: anti reflux mucosal ablation
ARMA
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 months after the initial procedure (ARMA or sham-procedure) patients are unblinded. Patients who initially received the sham procedure are now allowed to be treated by ARMA.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in symptoms of gastro esophageal reflux disease
timeFrame: 4 months
Secondary outcomes:
measure: Change in symptoms of gastro esophageal reflux disease
timeFrame: 12 months
measure: Change in symptoms of gastro esophageal reflux disease
timeFrame: 12 months
measure: Change in symptoms of gastro esophageal reflux disease
timeFrame: 12 months
measure: Change in symptoms of gastro esophageal reflux disease
timeFrame: 12 months
measure: Complication rate
timeFrame: 12 months
measure: PPI dependency
timeFrame: 12 months
measure: Change in esophageal acid exposure at 4 months after ARMA
timeFrame: 4 months after ARMA
measure: Change in lower esophageal sphincter pressure 4 months after ARMA
timeFrame: 4 months after ARMA
measure: Postinterventional pain
timeFrame: 1day
measure: Changes in cardia morphology
timeFrame: 4 months after ARMA
measure: Technical success rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
state: Bayern
Study officials:
affiliation: Universitiy Hospital Rechts der Isar, Technical Universitiy Munich
name: Mohamed Abdelhafez, MD
role: PRINCIPAL_INVESTIGATOR
References: