Usefulness of Wireless pH Monitoring in GERD Diagnosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Usefulness of Wireless pH Monitoring in the Diagnosis of Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Device: 96-hour off IBP wireless pH monitoring capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included. | Device: 96-hour off IBP wireless pH monitoring capsule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD Proportion | estimate the proportion of GERD measured by wireless pH monitoring capsule in patients in the gray area | june 2021-june 2023 | 
| Therapeutic response | To compare the GERDq scale before and after treatment with proton pump inhibitors. | june 2021-june 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gray area, gastroesophageal reflux disease, wireless pH monitoring