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Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931593
First Posted: July 2, 2009
Last Update Posted: July 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospices Civils de Lyon
  Purpose

Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.

The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.

Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.


Condition Intervention
Healthy Volunteers Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.

Secondary Outcome Measures:
  • To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.
  • To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.

Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: volunteers

This is a descriptive study to compare two techniques (manometry with perfused dentsleeve probe vs high resolution manometry for the identification of tLESr). Each subject is his own control.

The date of perfused manometry is randomized to avoid bias due to examinations' order.

Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)

Visit V0 (day 0 - 2 to 14 days):

  • Subject selection
  • Obtaining of written informed consent

Visit V1 (day 0):

  • Fasting subject
  • Randomization to determine the examination order
  • Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial)

Visit V2 (day 0 + 1 day): Phone contact

Visit V3 (day 0 + 2 to 7 days):

  • Same as V1

Visit V4 (V3 + 1 day): Phone contact and end of the study


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female between 18 and 60 years
  2. Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
  3. Subject without any medication (except oral contraception)
  4. Subject without previous digestive surgery history (except appendicectomy)
  5. Capability to pass manometric probes through each nostril
  6. Subject with health insurance
  7. Written informed consent
  8. No participation to another study at the same time

Exclusion Criteria:

  1. Age under 18 years or upper 60
  2. Pregnant woman or lactation
  3. Incapability to give consent
  4. No written informed consent
  Contacts and Locations
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): NCT00931593


Contacts
Contact: ROMAN Sabine, MD 04 72 11 01 36 sabine.roman@chu-lyon.fr

Locations
France
Hôpital St André, CHU BORDEAUX Not yet recruiting
Bordeaux, France, 33075
Contact: ZERBIB Frank, MD    05 56 79 58 06    frank.zerbib@chu-bordeaux.fr   
Principal Investigator: ZERBIB Frank, MD         
Hôpital Edouard Herriot - Hospices Civils de Lyon Recruiting
Lyon, France, 69437
Contact: ROMAN Sabine    04 72 11 01 36    sabine.roman@chu-lyon.fr   
Principal Investigator: ROMAN Sabine, MD         
Sub-Investigator: MION François, MD         
Hôpital Hôtel Dieu, CHU NANTES Not yet recruiting
Nantes, France, 44093
Contact: BRULEY DES VARANNES Stanislas, MD    02 40 08 31 65      
Principal Investigator: BRULEY DE VARANNES Stanislas, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: ROMAN Sabine, MD Hospices Civils de Lyon
Principal Investigator: MION François, MD Hospices Civils de Lyon
Principal Investigator: BRULEY DES VARANNES Stanislas, MD CHRU NANTES
Principal Investigator: ZERBIB Frank, MD CHRU BORDEAUX
  More Information

Responsible Party: Dr Sabine ROMAN, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00931593     History of Changes
Other Study ID Numbers: 2008.546/47
First Submitted: July 1, 2009
First Posted: July 2, 2009
Last Update Posted: July 2, 2009
Last Verified: July 2009

Keywords provided by Hospices Civils de Lyon:
Transient lower esophageal sphincter relaxation
high resolution manometry
dentsleeve probe
healthy volunteers