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

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ClinicalTrials.gov Identifier: NCT00941421
Recruitment Status : Terminated
First Posted : July 17, 2009
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : September 2009
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
videocapsul and OGDFE
Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy
Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
each patient receive one OVC and one OGDFE the same day



Primary Outcome Measures :
  1. Presence or not of oesophagal varix [ Time Frame: each fiberoptic endoscopy ]

Secondary Outcome Measures :
  1. Presence of OV with red signs [ Time Frame: each exam ]
  2. Presence of big VO or VO with red signs diagnosed by the two exams [ Time Frame: each patient ]
  3. Discrimination threshold for OV prediction [ Time Frame: each exam ]
  4. analogical visual scale for tolerance of each exam [ Time Frame: 30 days after last exam ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941421


Locations
France
CHU Angers
Angers, France, 49000
CH Avicenne
Bobigny, France, 93009
CH Beaujon
Clichy, France, 92118
CH Saint Philibert
Lomme, France, 59462
CH Lyon - Herriot
Lyon, France
Hôpital la conception
Marseille, France, 13385
CHU Nantes
Nantes, France, 44000
CH Cochin
Paris, France, 75000
CHU Bordeaux
Pessac, France, 33604
CHU Strasbourg
Strasbourg, France, 67091
CHU Toulouse - Purpan
Toulouse, France, 31059
Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00941421     History of Changes
Other Study ID Numbers: BRD 09/5-G
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hypertension, Portal
Liver Diseases
Digestive System Diseases