Usefulness of Wireless pH Monitoring in GERD Diagnosis

NCT ID: NCT05452603

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-20
• Study Completion Date: 2024-07-20

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.

Conditions

Gastroesophageal Reflux

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Study group

Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.

96-hour off IBP wireless pH monitoring capsule

Intervention Type: DEVICE

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.

Interventions

96-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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas José de San Martín

OTHER

Sponsor Role: lead

Responsible Party

Maria Marta Piskorz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

27251302710

Identifier Type: -

Identifier Source: org_study_id