Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers

• Registration Number: NCT01956877
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

To assess normal values of EGJ distensibility in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Study Start: 2013-11
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Establishing a cut-off value of EGJ distensibility (mm2/mmHg) based on the 90% percentile distribution of measurements performed in healthy volunteers.	3 months

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands