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

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ClinicalTrials.gov Identifier: NCT01844440
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Procedure: High resolution manometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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.




Primary Outcome Measures :
  1. tLESRs characteristics [ Time Frame: 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)

  2. Reflux underlying mechanisms [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844440


Locations
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France
Service d'hépato-gastroentérologie et oncologie digestive
Bordeaux, France, 33075
Service d'Exploration Fonctionnelle Digestive
Lyon, France, 69437
Institut des Maladies de l'Appareil Digestif (IMAD)
Nantes, France, 44000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Frank ZERBIB, MD-PhD University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01844440    
Other Study ID Numbers: CHUBX 2012/25
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Bordeaux:
GERD
tLESR
impedance
manometry
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases