Anti-reflux mucosectomy for gastroesophageal reflux disease: efficacy and mechanism of action.
- Conditions
- Gastroesophageal reflux diseasemotility disorder of the esophagus10017977
- Registration Number
- NL-OMON55769
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
- 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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the total number of reflux episodes assessed during<br /><br>ambulatory 24-h pH-impedance studies</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include total 24-h acid exposure time, prevalence of<br /><br>TLESRs, EGJ morphology, grade of reflux esophagitis and hiatal hernia, symptoms<br /><br>and quality of life scores and procedure-related complications. </p><br>