Usefulness of Wireless pH Monitoring in GERD Diagnosis
- Conditions
- Gastroesophageal Reflux
- Interventions
- Device: 96-hour off IBP wireless pH monitoring capsule
- Registration Number
- NCT05452603
- Lead Sponsor
- Hospital de Clinicas José de San Martín
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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. .
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group 96-hour off IBP wireless pH monitoring capsule Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Clinicas Jose de San Martin. Buenos Aires University
🇦🇷Buenos Aires, Argentina