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

Not Applicable

Terminated

• Conditions: Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context
• Interventions: Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy

• Registration Number: NCT00941421
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2009-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
videocapsul and OGDFE	oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy	Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy

Primary Outcome Measures

Name	Time	Method
Presence or not of oesophagal varix	each fiberoptic endoscopy

Secondary Outcome Measures

Name	Time	Method
Discrimination threshold for OV prediction	each exam
Presence of OV with red signs	each exam
Presence of big VO or VO with red signs diagnosed by the two exams	each patient
analogical visual scale for tolerance of each exam	30 days after last exam

Trial Locations

Locations (11)

CH Beaujon; 🇫🇷 Clichy, France

CH Saint Philibert; 🇫🇷 Lomme, France

Hôpital la conception; 🇫🇷 Marseille, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Bordeaux; 🇫🇷 Pessac, France

CH Cochin; 🇫🇷 Paris, France

CH Avicenne; 🇫🇷 Bobigny, France

CHU Toulouse - Purpan; 🇫🇷 Toulouse, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CH Lyon - Herriot; 🇫🇷 Lyon, France

CHU Angers; 🇫🇷 Angers, France