Gastroesophageal Reflux
Conditions
Keywords
anti reflux mucosal ablation, ARMA
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.
Interventions
PROCEDUREAnti 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.
PROCEDURESham 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.
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
| 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 |
Countries
Germany
Contacts
Primary ContactMohamed Abdelhafez, MD
Backup ContactRami Abbassi, MD
Outcome results
None listed