Clinical trial NCT00941421: Value of Oesophagal Videocapsul and Oeso-gastro-duodenal Fiber Endoscopy for the Screening of Oesophagal Varix for Cirrhotic Patients
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
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Presence or not of oesophagal varix
timeFrame: each fiberoptic endoscopy
Secondary outcomes:
measure: Presence of OV with red signs
timeFrame: each exam
measure: Presence of big VO or VO with red signs diagnosed by the two exams
timeFrame: each patient
measure: Discrimination threshold for OV prediction
timeFrame: each exam
measure: analogical visual scale for tolerance of each exam
timeFrame: 30 days after last exam
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bobigny
country: France
facility: CH Avicenne
city: Clichy
country: France
facility: CH Beaujon
city: Lomme
country: France
facility: CH Saint Philibert
city: Lyon
country: France
facility: CH Lyon - Herriot
city: Marseille
country: France
facility: Hôpital la conception
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: CH Cochin
city: Pessac
country: France
facility: CHU Bordeaux
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse - Purpan
Study officials:
References:
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.
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.