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

Gastroesophageal Reflux Disease Clinical Trial

— HRM RTSIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844440
• Other study ID #: CHUBX 2012/25
• Status: Completed
• Phase: N/A
• First received: March 1, 2013
• Last updated: July 1, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Service d'hépato-gastroentérologie et oncologie digestive	Bordeaux
France	Service d'Exploration Fonctionnelle Digestive	Lyon
France	Institut des Maladies de l'Appareil Digestif (IMAD)	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tLESRs characteristics	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)	Inclusion (Day 0)	No
Primary	Reflux underlying mechanisms	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	Inclusion (Day 0)	No