Back to resultsDiagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD (HRM RTSIO)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High resolution manometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring GERD, tLESR, impedance, manometry
Eligibility Criteria
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
Sites / Locations
- Service d'hépato-gastroentérologie et oncologie digestive
- Service d'Exploration Fonctionnelle Digestive
- Institut des Maladies de l'Appareil Digestif (IMAD)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HRM
Arm Description
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01844440
First Posted
March 1, 2013
Last Updated
July 1, 2014
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01844440
Brief Title
Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD
Acronym
HRM RTSIO
Official Title
Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD, tLESR, impedance, manometry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HRM
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
High resolution manometry
Intervention Description
Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
Primary Outcome Measure Information:
Title
tLESRs characteristics
Description
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)
Time Frame
Inclusion (Day 0)
Title
Reflux underlying mechanisms
Description
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
Time Frame
Inclusion (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank ZERBIB, MD-PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'hépato-gastroentérologie et oncologie digestive
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Service d'Exploration Fonctionnelle Digestive
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Institut des Maladies de l'Appareil Digestif (IMAD)
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD
We'll reach out to this number within 24 hrs