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

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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Procedure: High resolution manometry

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33075
    • Service d'hépato-gastroentérologie et oncologie digestive
  • Lyon, France, 69437
    • Service d'Exploration Fonctionnelle Digestive
  • Nantes, France, 44000
    • Institut des Maladies de l'Appareil Digestif (IMAD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HRM	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Frank ZERBIB, MD-PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (ESTIMATE): May 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 2, 2014
• Last Update Submitted That Met QC Criteria: July 1, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: GERD; impedance; manometry; tLESR
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: CHUBX 2012/25