Dysphagia Clinical Trial
Official title:
Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained 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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03 | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
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 |
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