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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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videocapsul and OGDFE

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

Group Type OTHER

oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy

Intervention Type DEVICE

each patient receive one OVC and one OGDFE the same day

Interventions

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oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy

each patient receive one OVC and one OGDFE the same day

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No