APDG: Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD

Sponsor

Technical University of Munich (Other)

Overall Status

Recruiting

CT.gov ID

NCT05763485

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Procedure: Anti reflux mucosal ablation (ARMA) Procedure: Sham procedure	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Single (Participant)

Masking Description:

Patients are randomized equally into an intervention and control group. The patients remain blinded to the procedure until 4 months after the initial procedure.

Primary Purpose:

Treatment

Official Title:

Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD: a Prospective Randomized, Single-blinded, Sham-controlled Trial

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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.
Sham Comparator: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: 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.

Sham Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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

Change in symptoms of gastro esophageal reflux disease [12 months]
Change in symptoms of gastro esophageal reflux disease in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 6 and 12 months. Total score 0-50; higher scores indicate greater complaints.
Change in symptoms of gastro esophageal reflux disease [12 months]
Change in symptoms of gastro esophageal reflux disease in regurgitation score at 4, 6 and 12 months. Total score 0-30; higher scores indicate greater complaints.
Change in symptoms of gastro esophageal reflux disease [12 months]
Change in symptoms of gastro esophageal reflux disease in Frequency scale for the symptoms of GERD (FSSG) at 4, 6 and 12 months. Total score 0-48; higher scores indicate greater complaints.
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.
Complication rate [12 months]
Recording of all complications in relation to the ARMA- procedure
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
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.
Changes in cardia morphology [4 months after ARMA]
Changes in Hill's flap grade
Technical success rate [1 day]
Successful completion of ARMA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	Munich	Bayern	Germany	81675

Sponsors and Collaborators

Technical University of Munich

Investigators

Principal Investigator: Mohamed Abdelhafez, MD, Universitiy Hospital Rechts der Isar, Technical Universitiy Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Abdelhafez, Principal Investigator Dr. Abdelhafez, Technical University of Munich

ClinicalTrials.gov Identifier:

NCT05763485

Other Study ID Numbers:

R0001

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Abdelhafez, Principal Investigator Dr. Abdelhafez, Technical University of Munich

anti reflux mucosal ablation

ARMA

Additional relevant MeSH terms:

Gastroesophageal Reflux

Study Results

No Results Posted as of Mar 10, 2023