Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

Brief Summary

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The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.

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Detailed Description

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tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors. HRM is the gold standard for detecting and characterizing tLESR, and could be considered as part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the objective definition of tLESRs in GERD patients have to be established, as it has been done in healthy patients Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HRM

Group Type EXPERIMENTAL

High resolution manometry

Intervention Type PROCEDURE

Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Interventions

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High resolution manometry

Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients 18 to 75 years old
* GERD documented by :

* Typical reflux symptoms (heartburn, regurgitations) completely responsive to PPI therapy
* And/or erosive esophagitis or Barrett's esophagus at endoscopy
* And/or positive pH 24h monitoring (acid exposure time \> 5% or positive symptom association indices)
* Possibility of easily positioned transnasal catheter
* Patients covered by social security
* Subjects must provide written, free and informed consent

Exclusion Criteria

* Pregnant or lactating women
* History of digestive or thoracic surgery (except appendicectomy)
* Patients unable to stop PPI therapy for 7 days
* Subjects unable to provide written consent, including adult under guardianship and emergency situation
* Simultaneous participation in another study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No