Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

Study Overview
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Brief Summary
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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.

Official Title
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Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.

Conditions
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Healthy Volunteers

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female between 18 and 60 years Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain) Subject without any medication (except oral contraception) Subject without previous digestive surgery history (except appendicectomy) Capability to pass manometric probes through each nostril Subject with health insurance Written informed consent No participation to another study at the same time Exclusion Criteria: Age under 18 years or upper 60 Pregnant woman or lactation Incapability to give consent No written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteers<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transient lower esophageal sphincter relaxation, high resolution manometry, dentsleeve probe, healthy volunteers