Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening ContextVCO-VONCT00941421
Value of Oesophagal Videocapsul and Oeso-gastro-duodenal Fiber Endoscopy for the Screening of Oesophagal Varix for Cirrhotic Patients
A study testing oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy in people with Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context, run by Nantes University Hospital at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context
- What is being tested?
- oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 11 sitesFrance
- Study dates
- Sep 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18< age< 80
- Diagnosis of a cirrhosis
- suspicion of portal hypertension without known diagnosis of a cirrhosis
- Able to give an inform consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Angers
Angers, 49000
CH Avicenne
Bobigny, 93009
CH Beaujon
Clichy, 92118
CH Saint Philibert
Lomme, 59462
CH Lyon - Herriot
Lyon
Hôpital la conception
Marseille, 13385
CHU Nantes
Nantes, 44000
CH Cochin
Paris, 75000
CHU Bordeaux
Pessac, 33604
CHU Strasbourg
Strasbourg, 67091
CHU Toulouse - Purpan
Toulouse, 31059
About this study
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
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.
- Being tested
- oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopyDevice
each patient receive one OVC and one OGDFE the same day
| Study group | Role | What they receive |
|---|---|---|
| videocapsul and OGDFE | Other | Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy Receives: Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or not of oesophagal varix
Measured: each fiberoptic endoscopy
Secondary outcomes (4)
Presence of OV with red signs
Measured: each exam
Presence of big VO or VO with red signs diagnosed by the two exams
Measured: each patient
Discrimination threshold for OV prediction
Measured: each exam
analogical visual scale for tolerance of each exam
Measured: 30 days after last exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening ContextStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941421
- Sponsor's protocol ID
- BRD 09/5-G
- Acronym
- VCO-VO
- Status last verified
- Jun 2013
- First submitted
- 16 Jul 2009
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28622450Sacher-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.
PubMed 25730284
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00941421
- Acronym / sponsor ID
- VCO-VO / BRD 09/5-G
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| videocapsul and OGDFE | Other | Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopyEach patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18< age< 80
- Diagnosis of a cirrhosis
- suspicion of portal hypertension without known diagnosis of a cirrhosis
- Able to give an inform consent
Key exclusion criteria (14 listed)
- Related to pouplation
- case history of cancer or oesophagal surgery
- case history of an ORL cancer
- case history of evolutive cancer
- Related to pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopyeach patient receive one OVC and one OGDFE the same day | Device | videocapsul and OGDFE |
Primary outcome
Presence or not of oesophagal varix
Time frame: each fiberoptic endoscopy
4 secondary outcomes
Presence of OV with red signs
Time frame: each exam
Presence of big VO or VO with red signs diagnosed by the two exams
Time frame: each patient
Discrimination threshold for OV prediction
Time frame: each exam
analogical visual scale for tolerance of each exam
Time frame: 30 days after last exam
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Derived from this study: PubMed 28622450Cales 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.
- Derived from this study: PubMed 25730284Sacher-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy in people with Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context, run by Nantes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or not of oesophagal varix (time frame: each fiberoptic endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941421, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.