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

University Hospital of Bordeaux

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: High resolution manometry

Study type: Interventional

Funder types: Other

Identifiers

NCT01844440

CHUBX 2012/25

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

HRM

Experimental group

Treatment:

Procedure: High resolution manometry