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The International Imaging Registry in Liver Cirrhosis (BAVENO-VI SPSS GROUP).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02692430
Recruitment Status : Unknown
Verified October 2016 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2016
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
IRCCS Policlinico S. Donato
Martin-Luther-Universität Halle-Wittenberg
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramon y Cajal
Odense University Hospital
Puerta de Hierro University Hospital
Royal Free Hospital NHS Foundation Trust
University of Alberta
University Hospital, Bonn
University Hospital, Gasthuisberg
Vienna General Hospital
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

The purpose of this study is to perform a multicentre registry of cirrhotic patients who had been submitted to an imagining technique in recent years (angio-CT scan or abdominal MRI), in order to collect anatomical and clinical information. The main objective will be focused on the study of portosystemic shunts and their relation with portal hypertension.

Patient with liver cirrhosis submitted to an abdominal angio-CT scan or a MRI from year 2010 to 2014 will be included in the study. The chosen imaging technique will be angio-CT preferably, but MRI data will also be available. Patients will be identified in every hospital by means of the registry of coded diagnoses and the lists of complementary tests performed. Clinical and radiological data of every patient will be collected. The clinical variables will be obtained from reviewing the patient clinical history. The radiological parameters will be gathered by means of the systematic review of the angio-CT or MRI.


Condition or disease Intervention/treatment
Liver Cirrhosis Portal Hypertension Hepatic Encephalopathy Other: No intervention is studied

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: LARGE SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSSs) IN PATIENTS WITH LIVER CIRRHOSIS. CLINICAL AND RADIOLOGICAL CHARACTERISTICS.
Study Start Date : April 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017





Primary Outcome Measures :
  1. Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI [ Time Frame: 4 years ]
  2. Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Type of portosystemic shunts detected by angio-CT scan or MRI [ Time Frame: 4 years ]
  2. Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome) [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cirrhotic patients submitted to a angio-CT or MRI in several centres of international relevancy in the management of this condition.
Criteria

Inclusion Criteria:

  • Liver cirrhosis
  • An evaluable imaging test (angio-CT or MRI) performed by any reason in the study period (from January 2010 to December 2014)

Exclusion Criteria:

  • Presence of previous surgical shunts
  • Prior liver transplant
  • Neurological or psychiatric disorder that do not permit to establish the diagnosis of hepatic encephalopathy
  • Presence of hepatocellular carcinoma beyond Milan criteria
  • Terminal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692430


Locations
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Spain
Vall d'Hebron Hospital
Barcelona, Spain
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
IRCCS Policlinico S. Donato
Martin-Luther-Universität Halle-Wittenberg
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramon y Cajal
Odense University Hospital
Puerta de Hierro University Hospital
Royal Free Hospital NHS Foundation Trust
University of Alberta
University Hospital, Bonn
University Hospital, Gasthuisberg
Vienna General Hospital
Investigators
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Principal Investigator: Joan Genesca, MD Vall d´Hebron Research Institut. Hospital Vall d´Hebron. Barcelona, Spain.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02692430    
Other Study ID Numbers: LIVIMIAGE-129
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Portosystemic Shunt
Hepatic encephalopathy
Portal hypertension
Liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Hypertension, Portal
Brain Diseases
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases