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Esophageal High Resolution Manometry and Dysphagia

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Dysphagia

Treatments

Device: High resolution manometry
Device: Conventional manometry

Study type

Interventional

Funder types

Other

Identifiers

NCT01284894
2010.624/28

Details and patient eligibility

About

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.

Enrollment

247 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

247 participants in 2 patient groups

Conventional manometry
Other group
Treatment:
Device: Conventional manometry
High resolution manometry
Experimental group
Treatment:
Device: High resolution manometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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