Usefulness of Wireless pH Monitoring in GERD Diagnosis

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Device: 96-hour off IBP wireless pH monitoring capsule

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1622
    • Hospital de Clinicas Jose de San Martin. Buenos Aires University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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. .

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas José de San Martín

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2021
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): July 20, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: gastroesophageal reflux disease; gray area; wireless pH monitoring
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Gastroenteritis; Duodenal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophagitis; Peptic Ulcer; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: 27251302710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes