Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

NCT ID: NCT00931593

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Hospices Civils de Lyon

Principal Investigators

ROMAN Sabine, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

MION François, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

BRULEY DES VARANNES Stanislas, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU NANTES

ZERBIB Frank, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU BORDEAUX

Locations

Hôpital St André, CHU BORDEAUX

Bordeaux, , France

Site Status: NOT_YET_RECRUITING

Hôpital Edouard Herriot - Hospices Civils de Lyon

Lyon, , France

Site Status: RECRUITING

Hôpital Hôtel Dieu, CHU NANTES

Nantes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

ROMAN Sabine, MD

Role: CONTACT

sabine.roman@chu-lyon.fr

04 72 11 01 36

Facility Contacts

ZERBIB Frank, MD

Role: primary

frank.zerbib@chu-bordeaux.fr

05 56 79 58 06

ROMAN Sabine

Role: primary

sabine.roman@chu-lyon.fr

04 72 11 01 36

BRULEY DES VARANNES Stanislas, MD

Role: primary

02 40 08 31 65

Other Identifiers

2008.546/47

Identifier Type: -

Identifier Source: org_study_id