Gastroesophageal Reflux
Conditions
Keywords
gastroesophageal reflux disease, gray area, wireless pH monitoring
Brief summary
Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area. The objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.
Detailed description
Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included. A 96-hour off IBP wireless pH monitoring capsule will be performed. The worst day, the average of the 4 days and the presence of 2 or more days with AET\>6% and the 4 days with AET\<4% will be recorded. Patients will be categorized into GERD, reflux hypersensitivity, and functional heartburn. A treatment will be established based on these categories and the GERDq will be measured at 8 weeks of treatment.
Interventions
DEVICE96-hour off IBP wireless pH monitoring capsule
The endoscopic pH measurement capsule will be placed 6cm above the squamocolumnar junction, determined endoscopically, in the sedated patient. Then the plot will be read.
Sponsors
Hospital de Clinicas José de San Martín
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years of age, with symptoms of gastroesophageal reflux, who have undergone a 24-hour impedance pH study without proton pump inhibitors (PPIs), whose AET is between 4 and 6% will be included consecutively. .
Exclusion criteria
* Patients with severe comorbidities: Liver cirrhosis, oncological disease, autoimmune diseases, cognitive impairment, psychiatric diseases, bleeding diathesis or anticoagulation * Pregnant women * Patients with severe esophagitis, esophageal varices, esophageal strictures, Barrett's esophagus, anti-reflux surgery * Patients with history of pacemaker or defibrillator, since they can interfere with the signal. * Patients with nickel allergy * Patients that refuses to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GERD Proportion | june 2021-june 2023 | estimate the proportion of GERD measured by wireless pH monitoring capsule in patients in the gray area |
| Therapeutic response | june 2021-june 2023 | To compare the GERDq scale before and after treatment with proton pump inhibitors. |
Countries
Argentina
Outcome results
None listed