Value of Oesophagal Videocapsul and Oeso-gastro-duodenal Fiber Endoscopy for the Screening of Oesophagal Varix for Cirrhotic Patients (VCO-VO)

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context

Treatments: Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00941421

BRD 09/5-G

Details and patient eligibility

About

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.

Enrollment: 310 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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310 participants in 1 patient group

videocapsul and OGDFE

Other group

Description:

Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy

Treatment:

Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy