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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: High resolution manometry

• Registration Number: NCT01844440
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-03-01
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-05-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRM	High resolution manometry	-

Primary Outcome Measures

Name	Time	Method
tLESRs characteristics	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	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

Trial Locations

Locations (3)

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

Institut des Maladies de l'Appareil Digestif (IMAD); 🇫🇷 Nantes, France

Service d'Exploration Fonctionnelle Digestive; 🇫🇷 Lyon, France