Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
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. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female between 18 and 60 years
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Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
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Subject without any medication (except oral contraception)
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Subject without previous digestive surgery history (except appendicectomy)
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Capability to pass manometric probes through each nostril
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Subject with health insurance
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Written informed consent
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No participation to another study at the same time
Exclusion Criteria:
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Age under 18 years or upper 60
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Pregnant woman or lactation
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Incapability to give consent
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No written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital St André, CHU BORDEAUX | Bordeaux | France | 33075 | |
| 2 | Hôpital Edouard Herriot - Hospices Civils de Lyon | Lyon | France | 69437 | |
| 3 | Hôpital Hôtel Dieu, CHU NANTES | Nantes | France | 44093 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2008.546/47