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

July 16, 2009
June 11, 2013
September 2009
February 2013   (final data collection date for primary outcome measure)
Presence or not of oesophagal varix [ Time Frame: each fiberoptic endoscopy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941421 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Value of Oesophagal Videocapsul and Oeso-gastro-duodenal Fiber Endoscopy for the Screening of Oesophagal Varix for Cirrhotic Patients
"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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context
Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
each patient receive one OVC and one OGDFE the same day
videocapsul and OGDFE
Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy
Intervention: Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
310
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00941421
BRD 09/5-G
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP