Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-04 @ 5:49 PM
Study NCT ID:
NCT02530567
Status:
TERMINATED
Last Update Posted:
2019-08-21
First Post:
2015-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Evaluation of Portal Pressure by MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'recruitment defect', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2015-08-20', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI.', 'timeFrame': '1 week', 'description': 'MRI and catheterization will be performed the same week.\n\nFor the azygos blood flow (by MRI), measures will be repeated 5 times. Speed of extraction and the rate on the post processing console will be made with a double reading.\n\nFor the measurement of portal pressure by catheterization, will be performed measurements of occluded hepatic vein pressure and free hepatic vein.\n\nThey will be repeated 3 times each.\n\nThese measures will be carried out to calculate the portosystemic pressure gradient.\n\nThe flow rate and gradient measurements will be performed blindly to the other.'}], 'secondaryOutcomes': [{'measure': 'Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.', 'timeFrame': '1 week', 'description': 'This outcome is different of primary outcome because the Measurement of azygos blood flow (MRI) is repeated on a strictly perpendicular section to the vessel facing the T4-T5 disk and the extraction speed rate and on post processing console is made by double reading.\n\nMeasuring portal pressure by catheterization. Measurements of occluded hepatic vein pressure and free hepatic vein and will be repeated 3 times each.\n\nFlow measurements and gradient will be carried out blind to each other by the radiologist and the hepatologist.'}, {'measure': 'Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.', 'timeFrame': '1 week', 'description': 'Measurement of azygos blood flow (MRI) Repeated Measure 5 times on a strictly perpendicular cut to the vessel immediately after anastomosis of the hepatic veins to the inferior vena cava and Extraction speed and flow on post processing console with double reading.\n\nMeasurement of portal pressure by catheterization It will be defined by the measures of occluded hepatic vein pressure and free hepatic vein and measurements will be repeated 3 times each.\n\nThe flow rate and gradient measurements will be performed blindly to the other.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['portal pressure', 'portosystemic pressure gradient', 'azygos blood flow'], 'conditions': ['Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '18328931', 'type': 'BACKGROUND', 'citation': 'Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.'}, {'pmid': '18462268', 'type': 'BACKGROUND', 'citation': 'Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2.'}, {'pmid': '19724251', 'type': 'BACKGROUND', 'citation': 'Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.'}, {'pmid': '21274889', 'type': 'BACKGROUND', 'citation': 'Thabut D, Moreau R, Lebrec D. Noninvasive assessment of portal hypertension in patients with cirrhosis. Hepatology. 2011 Feb;53(2):683-94. doi: 10.1002/hep.24129.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.', 'detailedDescription': 'All patients will benefit from:\n\n* Pressure gradient measurement portosystemic\n* MRI measurement of azygos flow, aortic, portals, spleen and lower cellar\n* Liver biopsy\n* Laboratory tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspicion of chronic liver disease\n* Indication to perform a liver biopsy transjugular\n* Patient able to consent\n\nExclusion Criteria:\n\n* contraindication to MRI:\n* Holders of a pacemaker or a defibrillator, an implanted material activated by electrical, magnetic or mechanical\n* Holders of hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants\n* claustrophobic\n* Severe hepatic encephalopathy\n* Inability to MRI in the week surrounding the first jugular'}, 'identificationModule': {'nctId': 'NCT02530567', 'acronym': 'ENIP', 'briefTitle': 'Non-invasive Evaluation of Portal Pressure by MRI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Using MRI for a Non-invasive Evaluation of Portal Pressure', 'orgStudyIdInfo': {'id': 'RC31/14/7318'}, 'secondaryIdInfos': [{'id': 'University Hospital Toulouse', 'type': 'OTHER_GRANT', 'domain': '14731802'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The measurement of portosystemic pressure gradient will be performed before liver biopsy.\n\nThen liver biopsy is performed. The MRI was performed on the day of biopsy or within one week around the completion of the biopsy.\n\nThe MRI machine used is the Siemens 3T.', 'interventionNames': ['Procedure: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'PROCEDURE', 'description': 'All patients performing the biopsy will have an MRI to carry out the necessary measures.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'UH Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Phillipe OTAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH TOULOUSE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}