Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD
HRM RTSIO
1 other identifier
interventional
15
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJuly 2, 2014
July 1, 2014
9 months
March 1, 2013
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (1)
HRM
EXPERIMENTALInterventions
Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Service d'hépato-gastroentérologie et oncologie digestive
Bordeaux, Bordeaux, 33075, France
Service d'Exploration Fonctionnelle Digestive
Lyon, Lyon, 69437, France
Institut des Maladies de l'Appareil Digestif (IMAD)
Nantes, Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank ZERBIB, MD-PhD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2013
First Posted
May 1, 2013
Study Start
April 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
July 2, 2014
Record last verified: 2014-07