Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD

NCT ID: NCT05763485

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-01

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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Anti reflux mucosal ablation (ARMA)

Intervention Type: PROCEDURE

In patients fulfilling the inclusion criteria and being randomized for ARMA, the procedure using argon plasma coagulation involves two semicircular ablations of the mucosa of the EGJ in a butterfly shape of a width of 2 cm. The approximate duration of the procedure is 30min.

Follow includes objective evaluation of reflux disease by reflux questionnaires, esophagogastroduodenoscopy, esophageal manometry, pH metry.

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.

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: PROCEDURE

In patients fulfilling the inclusion criteria and being randomized for sham procedure, the procedure involves esophagogastroduodenoscopy with the same set of movements and duration as the ARMA procedure without the actual ablation.

Interventions

Anti reflux mucosal ablation (ARMA)

In patients fulfilling the inclusion criteria and being randomized for ARMA, the procedure using argon plasma coagulation involves two semicircular ablations of the mucosa of the EGJ in a butterfly shape of a width of 2 cm. The approximate duration of the procedure is 30min.

Follow includes objective evaluation of reflux disease by reflux questionnaires, esophagogastroduodenoscopy, esophageal manometry, pH metry.

Intervention Type: PROCEDURE

Sham procedure

In patients fulfilling the inclusion criteria and being randomized for sham procedure, the procedure involves esophagogastroduodenoscopy with the same set of movements and duration as the ARMA procedure without the actual ablation.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdelhafez

Principal Investigator Dr. Abdelhafez

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Abdelhafez, MD

Role: PRINCIPAL_INVESTIGATOR

Universitiy Hospital Rechts der Isar, Technical Universitiy Munich

Locations

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Mohamed Abdelhafez, MD

Role: CONTACT

Mohamed.Abdelhafez@mri.tum.de

08941409320

Rami Abbassi, MD

Role: CONTACT

rami.abbassi@mri.tum.de

08941409349

Facility Contacts

Mohamed Abdelhafez, MD

Role: primary

mohamed.abdelhafez@tum.de

+49894140 ext. 9320

Rami Abbassi, MD

Role: backup

rami.abbassi@mri.tum.de

08941409349

Other Identifiers

R0001

Identifier Type: -

Identifier Source: org_study_id