Esophageal High Resolution Manometry and Dysphagia

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284894
• Other study ID #: 2010.624/28
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: January 14, 2014
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• Conventional manometry
Conventional esophageal manometry
• High resolution manometry
High resolution esophageal manometry

Locations

Country	Name	City	State
France	Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients correctly diagnosed for esophageal motility disorder		6 months	No
Secondary	Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)		24 hours	Yes
Secondary	Duration of examination and study analysis		day 0	No
Secondary	Cost of patient care within the 6 months following the manometry		6 months	No