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Esophageal High Resolution Manometry and Dysphagia

Primary Purpose

Dysphagia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Conventional manometry

High resolution manometry

About this trial

This is an interventional diagnostic trial for Dysphagia focused on measuring Dysphagia, Conventional manometry, High resolution manometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Conventional manometry

High resolution manometry

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients correctly diagnosed for esophageal motility disorder

Secondary Outcome Measures

Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)

Duration of examination and study analysis

Cost of patient care within the 6 months following the manometry

Full Information

NCT ID

NCT01284894

First Posted

January 26, 2011

Last Updated

January 14, 2014

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01284894

Brief Title

Esophageal High Resolution Manometry and Dysphagia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia

Keywords

Dysphagia, Conventional manometry, High resolution manometry

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

247 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional manometry

Arm Type

Other

Arm Title

High resolution manometry

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Conventional manometry

Intervention Description

Conventional esophageal manometry

Intervention Type

Device

Intervention Name(s)

High resolution manometry

Intervention Description

High resolution esophageal manometry

Primary Outcome Measure Information:

Title

Percentage of patients correctly diagnosed for esophageal motility disorder

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)

Time Frame

24 hours

Title

Duration of examination and study analysis

Time Frame

day 0

Title

Cost of patient care within the 6 months following the manometry

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: