The feasibility of endoscopic functional luminal imaging probe in reflux disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004156
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 900
All patients who were between 15 and 79 years old, with reflux symptoms, and scheduled to undergo a screening gastroscopy and EndoFLIP® were included in this study. According to the results, patients with erosive esophagitis, determined by gastroscopy, were referred to the ERD group, while patients with no erosive esophagitis, but with abnormalities observed over 24-hour pH monitoring were classified as the NERD group.12 Healthy controls were on no regular medications and had no symptoms of reflux disease, but did have nonspecific symptoms, such as dyspepsia or abdominal discomfort.
(1) unable to receive a gastroscopy or EndoFLIP®; (2) unable to provide informed consent; (3) hemodynamic instability (systolic blood pressure [SBP] < 90 mmHg), or if the peripheral oxygen saturation (SpO2) was 90% in room air, or < 95% on 2 L/min of oxygen at baseline before the procedure; (4) psychological problems; (5) acute severe infection; (6) evidence of esophageal
motility disorder on esophageal manometry.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cross sectional area, distensiblity index
- Secondary Outcome Measures
Name Time Method Residual LES pressure, 24-hr ambulatory pH monitoring