Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33075
    • Not yet recruiting
    • Hôpital St André, CHU BORDEAUX
    • Contact: ZERBIB Frank, MD; Phone Number: 05 56 79 58 06; Email: frank.zerbib@chu-bordeaux.fr
    • Principal Investigator: ZERBIB Frank, MD
  • Lyon, France, 69437
    • Recruiting
    • Hôpital Edouard Herriot - Hospices Civils de Lyon
    • Contact: ROMAN Sabine; Phone Number: 04 72 11 01 36; Email: sabine.roman@chu-lyon.fr
    • Principal Investigator: ROMAN Sabine, MD
    • Sub-Investigator: MION François, MD
  • Nantes, France, 44093
    • Not yet recruiting
    • Hôpital Hôtel Dieu, CHU NANTES
    • Contact: BRULEY DES VARANNES Stanislas, MD; Phone Number: 02 40 08 31 65
    • Principal Investigator: BRULEY DE VARANNES Stanislas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Estimate): July 2, 2009
• Last Update Submitted That Met QC Criteria: July 1, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: healthy volunteers; high resolution manometry; Transient lower esophageal sphincter relaxation; dentsleeve probe
• Other Study ID Numbers: 2008.546/47