Esophageal High Resolution Manometry and Dysphagia

January 14, 2014 updated by: Hospices Civils de Lyon

Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female older than 18 years
  • Patient with unexplained dysphagia
  • Patient without cause of dysphagia on eso-gastro-duodenal endoscopy
  • Patient referred for esophageal manometry
  • Patient with health insurance
  • Informed consent signed

Exclusion Criteria:

  • Patient younger than 18 years
  • Allergy to one component of manometry catheter
  • Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry
  • Patient unable to give his consent or legally incompetent
  • Patient non qualified according to the investigator
  • Patient refusal or absence of informed consent signed
  • Concomitant participation to another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Conventional manometry
Device: Conventional manometry
Conventional esophageal manometry
EXPERIMENTAL: High resolution manometry
Device: High resolution manometry
High resolution esophageal manometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients correctly diagnosed for esophageal motility disorder
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)
Time Frame: 24 hours
24 hours
Duration of examination and study analysis
Time Frame: day 0
day 0
Cost of patient care within the 6 months following the manometry
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sabine ROMAN, Dr, Unité d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - 69437 Lyon Cedex 03- France
  • Principal Investigator: Stanislas BRULEY DES VARANNES, Service d'Hépato-Gastro-Entérologie - CHU Hôtel Dieu - Place A Ricordeau - 44093 Nantes Cedex - France
  • Principal Investigator: Franck ZERBIB, Service d'Hépato-Gastro-Entérologie - Hôpital Saint-André - 33075 Bordeaux Cedex - France
  • Principal Investigator: Guillaume GOURCEROL, Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen - 76031 Rouen Cedex - France
  • Principal Investigator: Silvana PERRETTA, Pole Hépato- Digestif, Service de Chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - 1 place de l'Hôpital - 67091 Strasbourg cedex - France
  • Principal Investigator: Franck ROPERT, Service d'Hépato-Gastro-Entérologie - CHU Pontchaillou - Rue H. le Guillou - 35033 Rennes cedex - France
  • Principal Investigator: François MION, MD, Service d'Hépato-Gastro-Entérologie, Hôpital de la Croix-Rousse , 69317 Lyon
  • Principal Investigator: Benoit COFFIN, MD, Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, 92700 Colombes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (ESTIMATE)

January 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010.624/28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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