Usefulness of Wireless pH Monitoring in GERD Diagnosis

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452603
• Other study ID #: 27251302710
• Status: Recruiting
• Start date: June 20, 2021
• Est. completion date: July 20, 2024

Study information

• Verified date: March 2024
• Source: Hospital de Clinicas José de San Martín
• Contact: MARIA M PISKORZ, MD
• Phone: +5491133192885
• Email: neurogastrohc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital de Clinicas Jose de San Martin. Buenos Aires University	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas José de San Martín

Country where clinical trial is conducted

Argentina, 

Outcome

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