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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)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00941421
First received: July 16, 2009
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention
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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Presence or not of oesophagal varix [ Time Frame: each fiberoptic endoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of OV with red signs [ Time Frame: each exam ] [ Designated as safety issue: No ]
  • Presence of big VO or VO with red signs diagnosed by the two exams [ Time Frame: each patient ] [ Designated as safety issue: No ]
  • Discrimination threshold for OV prediction [ Time Frame: each exam ] [ Designated as safety issue: No ]
  • analogical visual scale for tolerance of each exam [ Time Frame: 30 days after last exam ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: September 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00941421     History of Changes
Other Study ID Numbers: BRD 09/5-G
Study First Received: July 16, 2009
Last Updated: June 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Varicose Veins
Vascular Diseases
 Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013