Gastroesophageal reflux disease motility disorder of the esophagus
Conditions
Interventions
All subjects will undergo ARMS. Reflux activity will be measured at baseline
and at 3 months follow-up with both ambulatory and prolonged postprandial
stationary pH-impedance measurements. Concomita
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Gastroesophageal reflux disease confirmed by a 24-h ambulatory pH-impedance study (symptom association probability *95%; esophageal acid exposure *4%) - Symptoms of heartburn, regurgitation and/or chest pain under PPI-treatment for at least 3 months at least 3 times a week. - Use of proton pump inhibitors at a standard dose twice a day for at least 4 weeks prior to inclusion.
Exclusion criteria
Exclusion criteria: - ASA classification of III or higher. - Previous (surgical or endoscopic) anti-reflux procedure - Previous surgery of the stomach or esophagus - Sliding hiatal hernia >2cm - Esophagitis grade C or D - Presence of Barrett*s esophagus with dysplasia - Known coagulopathy - Unable to stop coagulants (with the exception of mono antiplatelet therapy) - Presence of liver cirrhosis and/or esophageal varices - Presence of a stricture of the esophagus - Presence of eosinophilic esophagitis - Presence of achalasia - Presence of connective tissue disorder - Absent peristalsis on high-resolution manometry - Pregnancy at time of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the total number of reflux episodes assessed during ambulatory 24-h pH-impedance studies | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include total 24-h acid exposure time, prevalence of TLESRs, EGJ morphology, grade of reflux esophagitis and hiatal hernia, symptoms and quality of life scores and procedure-related complications. | — |
Countries
Netherlands
Outcome results
None listed