None listed
Conditions
Brief summary
To assess normal values of EGJ distensibility in healthy volunteers.
Interventions
None listed
Sponsors
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. No history of gastrointestinal disease, especially gastro-esophageal reflux disease 2. BMI = 18-30 kg/m² 3. Caucasian race 4. Subject signed the informed consent form and is able to adhere to study protocol
Exclusion criteria
1. Age \< 18 years 2. Previous esophageal or gastric surgery 3. Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering upper gastrointestinal endoscopy) 4. Patients using anticoagulants 5. Patients unable to give informed consent 6. Smoking 7. History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device | 3 months | EGJ distensibility as measured by the index of the narrowest cross sectional area (mm2) and the corresponding intrabag pressure (mmHg) |
Secondary
| Measure | Time frame |
|---|---|
| Establishing a cut-off value of EGJ distensibility (mm2/mmHg) based on the 90% percentile distribution of measurements performed in healthy volunteers. | 3 months |
Countries
Netherlands
Contacts
Primary ContactFabienne Smeets, MD
Backup ContactJosé M Conchillo, MD PhD
Outcome results
None listed