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Clinical Trials/NCT01284894
NCT01284894CompletedNot Applicable

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

Hospices Civils de Lyon2 sites in 1 country247 target enrollmentStarted: February 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
247
Locations
2
Primary Endpoint
Percentage of patients correctly diagnosed for esophageal motility disorder
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

High resolution manometry

Experimental

Intervention: High resolution manometry (Device)

Conventional manometry

Other

Intervention: Conventional manometry (Device)

Outcomes

Primary Outcomes

Percentage of patients correctly diagnosed for esophageal motility disorder

Time Frame: 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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