Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD

Gastroesophageal Reflux Clinical Trial

— APDG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763485
• Other study ID #: R0001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2023
• Source: Technical University of Munich
• Contact: Mohamed Abdelhafez, MD
• Phone: 08941409320
• Email: Mohamed.Abdelhafez[@]mri.tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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 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.

Locations

Country	Name	City	State
Germany	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	Munich	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in symptoms of gastro esophageal reflux disease	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.	4 months
Secondary	Change in symptoms of gastro esophageal reflux disease	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.	12 months
Secondary	Change in symptoms of gastro esophageal reflux disease	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.	12 months
Secondary	Change in symptoms of gastro esophageal reflux disease	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.	12 months
Secondary	Change in symptoms of gastro esophageal reflux disease	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.	12 months
Secondary	Complication rate	Recording of all complications in relation to the ARMA- procedure	12 months
Secondary	PPI dependency	Requirement and dose of PPI at 4, 6 and 12 months	12 months
Secondary	Change in esophageal acid exposure at 4 months after ARMA	Change in esophageal acid exposure in pH metry 4 months after ARMA	4 months after ARMA
Secondary	Change in lower esophageal sphincter pressure 4 months after ARMA	Change in lower esophageal sphincter pressure in manometry 4 months after ARMA	4 months after ARMA
Secondary	Postinterventional pain	Recording of postinterventional pain in visual analog scale (VAS). Higher scores indicate greater complaints.	1day
Secondary	Changes in cardia morphology	Changes in Hill's flap grade	4 months after ARMA
Secondary	Technical success rate	Successful completion of ARMA	1 day