ClinicalTrials.gov
ClinicalTrials.gov Menu

Esophageal High Resolution Manometry and Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284894
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Dysphagia Device: Conventional manometry Device: High resolution manometry Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia
Study Start Date : February 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Conventional manometry Device: Conventional manometry
Conventional esophageal manometry
Experimental: High resolution manometry Device: High resolution manometry
High resolution esophageal manometry



Primary Outcome Measures :
  1. Percentage of patients correctly diagnosed for esophageal motility disorder [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284894


Locations
France
Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03
Lyon, France, 69437
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: 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01284894     History of Changes
Other Study ID Numbers: 2010.624/28
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014

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