Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

Not Applicable

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

• Registration Number: NCT00931593
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Status Verified: 2009-07
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Last Update Submitted: 2009-07-01
• Study First Posted: 2009-07-02
• Last Update Posted: 2009-07-02
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
volunteers	Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Hôpital St André, CHU BORDEAUX; 🇫🇷 Bordeaux, France

Hôpital Hôtel Dieu, CHU NANTES; 🇫🇷 Nantes, France

Hôpital Edouard Herriot - Hospices Civils de Lyon; 🇫🇷 Lyon, France