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Completed

NCT Number: NCT01284894

Esophageal High Resolution Manometry and Dysphagia

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional manometry

Device

Conventional esophageal manometry

High resolution manometry

Device

High resolution esophageal manometry

Primary outcomes

  1. Percentage of patients correctly diagnosed for esophageal motility disorder

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2011
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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