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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)

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Angers
  • CH Avicenne
  • CH Beaujon
  • CH Saint Philibert
  • CH Lyon - Herriot
  • Hôpital la conception
  • CHU Nantes
  • CH Cochin
  • CHU Bordeaux
  • CHU Strasbourg
  • CHU Toulouse - Purpan

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

videocapsul and OGDFE

Arm Description

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

Outcomes

Primary Outcome Measures

Presence or not of oesophagal varix

Secondary Outcome Measures

Presence of OV with red signs
Presence of big VO or VO with red signs diagnosed by the two exams
Discrimination threshold for OV prediction
analogical visual scale for tolerance of each exam

Full Information

First Posted
July 16, 2009
Last Updated
June 11, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00941421
Brief Title
Value of Oesophagal Videocapsul and Oeso-gastro-duodenal Fiber Endoscopy for the Screening of Oesophagal Varix for Cirrhotic Patients
Acronym
VCO-VO
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
videocapsul and OGDFE
Arm Type
Other
Arm Description
Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy
Intervention Type
Device
Intervention Name(s)
oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
Intervention Description
each patient receive one OVC and one OGDFE the same day
Primary Outcome Measure Information:
Title
Presence or not of oesophagal varix
Time Frame
each fiberoptic endoscopy
Secondary Outcome Measure Information:
Title
Presence of OV with red signs
Time Frame
each exam
Title
Presence of big VO or VO with red signs diagnosed by the two exams
Time Frame
each patient
Title
Discrimination threshold for OV prediction
Time Frame
each exam
Title
analogical visual scale for tolerance of each exam
Time Frame
30 days after last exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CH Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CH Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
CH Saint Philibert
City
Lomme
ZIP/Postal Code
59462
Country
France
Facility Name
CH Lyon - Herriot
City
Lyon
Country
France
Facility Name
Hôpital la conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CH Cochin
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Toulouse - Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28622450
Citation
Cales P, Sacher-Huvelin S, Valla D, Bureau C, Olivier A, Oberti F, Boursier J, Galmiche JP; multicenter group VO-VCO. Large oesophageal varice screening by a sequential algorithm using a cirrhosis blood test and optionally capsule endoscopy. Liver Int. 2018 Jan;38(1):84-93. doi: 10.1111/liv.13497. Epub 2017 Jul 7.
Results Reference
derived
PubMed Identifier
25730284
Citation
Sacher-Huvelin S, Cales P, Bureau C, Valla D, Vinel JP, Duburque C, Attar A, Archambeaud I, Benamouzig R, Gaudric M, Luet D, Couzigou P, Planche L, Galmiche JP, Coron E. Screening of esophageal varices by esophageal capsule endoscopy: results of a French multicenter prospective study. Endoscopy. 2015 Jun;47(6):486-92. doi: 10.1055/s-0034-1391393. Epub 2015 Mar 2.
Results Reference
derived

Learn more about this trial

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

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