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Esophageal High Resolution Manometry and Dysphagia

This study is currently recruiting participants.
Verified July 2011 by Hospices Civils de Lyon
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01284894
First received: January 26, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Dysphagia
 Device: Conventional manometry
Device: High resolution manometry

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentage of patients correctly diagnosed for esophageal motility disorder [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Duration of examination and study analysis [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • Cost of patient care within the 6 months following the manometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 368
Study Start Date: February 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Conventional manometry Device: Conventional manometry
Conventional esophageal manometry
Experimental: High resolution manometry Device: High resolution manometry
High resolution esophageal manometry

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284894

Contacts
Contact: Sabine ROMAN, Dr +33 4 72 11 01 36 sabine.roman@chu-lyon.fr
Contact: François MION, Pr +33 4 72 11 01 38 francois.mion@chu-lyon.fr

Locations
France
Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03 Recruiting
Lyon, France, 69437
Contact: Sabine ROMAN     +33 4 72 11 01 36     sabine.roman@chu-lyon.fr    
Contact: François MION     +33 4 72 11 01 38     francois.mion@chu-lyon.fr    
Principal Investigator: Sabine ROMAN            
Sub-Investigator: François MION            
Sponsors and Collaborators
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: Véronique VITTON Service de Gastro-Entérologie - Hôpital Nord - Chemin des Bourrely - 13915 Marseille cedex 20 - France
Principal Investigator: Michel BOUCHOUCHA Service d'Exploration Fonctionnelle Digestive - Hôpital Avicenne - 125 rue de Stalingrad - 93009 Bobigny cedex - France
  More Information

No publications provided

Responsible Party: Dr Sabine ROMAN, Unité d'Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, 69437 Lyon cedex 03
ClinicalTrials.gov Identifier: NCT01284894     History of Changes
Other Study ID Numbers: 2010.624/28
Study First Received: January 26, 2011
Last Updated: July 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Dysphagia
Conventional manometry
High resolution manometry

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013