Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context Clinical Trial
— VCO-VOOfficial title:
"Comparision of Diagnostic Value of Oesophagal Videocapsul (VCO) and Oeso-gastro-duodenal Fiber Endoscopy (OGDFE) for the Screening of Oesophagal Varix (OV) for Cirrhotic Patients
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.
| Status | Terminated |
| Enrollment | 310 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Angers | Angers | |
| France | CH Avicenne | Bobigny | |
| France | CH Beaujon | Clichy | |
| France | CH Saint Philibert | Lomme | |
| France | CH Lyon - Herriot | Lyon | |
| France | Hôpital la conception | Marseille | |
| France | CHU Nantes | Nantes | |
| France | CH Cochin | Paris | |
| France | CHU Bordeaux | Pessac | |
| France | CHU Strasbourg | Strasbourg | |
| France | CHU Toulouse - Purpan | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Presence or not of oesophagal varix | each fiberoptic endoscopy | No | |
| Secondary | Presence of OV with red signs | each exam | No | |
| Secondary | Presence of big VO or VO with red signs diagnosed by the two exams | each patient | No | |
| Secondary | Discrimination threshold for OV prediction | each exam | No | |
| Secondary | analogical visual scale for tolerance of each exam | 30 days after last exam | No |