Esophageal High Resolution Manometry and Dysphagia

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Device: High resolution manometry; Device: Conventional manometry

• Registration Number: NCT01284894
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High resolution manometry	High resolution manometry	-
Conventional manometry	Conventional manometry	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients correctly diagnosed for esophageal motility disorder	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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