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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| volunteers | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization) | Device | Visit V0 (day 0 - 2 to 14 days):
Visit V1 (day 0):
Visit V2 (day 0 + 1 day): Phone contact Visit V3 (day 0 + 2 to 7 days):
Visit V4 (V3 + 1 day): Phone contact and end of the study |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ROMAN Sabine, MD | Contact | 04 72 11 01 36 | sabine.roman@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| ROMAN Sabine, MD | Hospices Civils de Lyon | Principal Investigator |
| MION François, MD | Hospices Civils de Lyon | Principal Investigator |
| BRULEY DES VARANNES Stanislas, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital St André, CHU BORDEAUX | Not yet recruiting | Bordeaux | 33075 | France |
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| ID | Term |
|---|---|
| D008365 | Manometry |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| CHRU NANTES |
| Principal Investigator |
| ZERBIB Frank, MD | CHRU BORDEAUX | Principal Investigator |
| Hôpital Edouard Herriot - Hospices Civils de Lyon | Recruiting | Lyon | 69437 | France |
|
| Hôpital Hôtel Dieu, CHU NANTES | Not yet recruiting | Nantes | 44093 | France |
|