Clinical trial NCT00931593: Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry
Official title: Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: Transient lower esophageal sphincter relaxation
high resolution manometry
dentsleeve probe
healthy volunteers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.
measure: To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital St André, CHU BORDEAUX
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Hospices Civils de Lyon
city: Nantes
country: France
facility: Hôpital Hôtel Dieu, CHU NANTES
Study officials:
affiliation: Hospices Civils de Lyon
name: ROMAN Sabine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: MION François, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU NANTES
name: BRULEY DES VARANNES Stanislas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU BORDEAUX
name: ZERBIB Frank, MD
role: PRINCIPAL_INVESTIGATOR
References: