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

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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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'hépato-gastroentérologie et oncologie digestive, Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High resolution manometry

Procedure

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

Primary outcomes

tLESRs characteristics

Time frame: Inclusion (Day 0)
To characterize tLESRs defined according following criteria:
- LES basal pressure (mmHg) defined as LES pressure during relaxation
- LES minimum pressure during relaxation
- Duration of the LES relaxation (seconds)
- Integrated relaxation pressure (4 seconds)
Reflux underlying mechanisms

Time frame: Inclusion (Day 0)
To detect every reflux and to determine underlying mechanisms
- Transient lower esophageal sphincter relaxations (tLESR)
- Low basal LES pressure (free reflux)
- Increased abdominal pressure
- Swallow
- Another mechanism

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: HRM RTSIO

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 1, 2013
Registry last updated: Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed