Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

NCT00931593 | Unknown

• 1 other identifier: 2008.546/47
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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

Keywords

Transient lower esophageal sphincter relaxation; high resolution manometry; dentsleeve probe; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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.

Study Arms (1)

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.

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

Interventions

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): * 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

volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female between 18 and 60 years
• Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
• Subject without any medication (except oral contraception)
• Subject without previous digestive surgery history (except appendicectomy)
• Capability to pass manometric probes through each nostril
• Subject with health insurance
• Written informed consent
• No participation to another study at the same time

You may not qualify if:

• Age under 18 years or upper 60
• Pregnant woman or lactation
• Incapability to give consent
• No written informed consent

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital St André, CHU BORDEAUX

Bordeaux, 33075, France

NOT YET RECRUITING

Hôpital Edouard Herriot - Hospices Civils de Lyon

Lyon, 69437, France

RECRUITING

Hôpital Hôtel Dieu, CHU NANTES

Nantes, 44093, France

NOT YET RECRUITING

MeSH Terms

Interventions

Manometry

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ROMAN Sabine, MD

CONTACT

04 72 11 01 36; sabine.roman@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 2, 2009

Record last verified: 2009-07

Locations

FR (3)