Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context
Conditions
Brief summary
The purpose of this study is to determine the equivalence or not of diagnosis ability of oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of oesophagal varix.
Interventions
DEVICEoesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
each patient receive one OVC and one OGDFE the same day
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18\< age\< 80 * Diagnosis of a cirrhosis * suspicion of portal hypertension without known diagnosis of a cirrhosis * Able to give an inform consent
Exclusion criteria
Related to pouplation * case history of cancer or oesophagal surgery * case history of an ORL cancer * case history of evolutive cancer Related to pathology * Previous fiberoptic endoscopy with OV diagnosis * Less than 6 month since last fiberoptic endoscopy Related to tested device * clinical suspicion of oesophagal stenosis for a patient presenting a dysphagia to solids * Zenker diverticuls attested * clinical suspicion of small intestinal stenosis * patient with pace-maker or any other inter device * pregnant women * deglutition troubles withfalse passage and/or conscience troubles
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or not of oesophagal varix | each fiberoptic endoscopy |
Secondary
| Measure | Time frame |
|---|---|
| Presence of OV with red signs | each exam |
| Presence of big VO or VO with red signs diagnosed by the two exams | each patient |
| Discrimination threshold for OV prediction | each exam |
| analogical visual scale for tolerance of each exam | 30 days after last exam |
Countries
France
Outcome results
None listed