The International Imaging Registry in Liver Cirrhosis (BAVENO-VI SPSS GROUP).
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|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
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|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI [ Time Frame: 4 years ]
- Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation [ Time Frame: 4 years ]
- Type of portosystemic shunts detected by angio-CT scan or MRI [ Time Frame: 4 years ]
- Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome) [ Time Frame: 4 years ]
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
|Vall d'Hebron Hospital|
|Principal Investigator:||Joan Genesca, MD||Vall d´Hebron Research Institut. Hospital Vall d´Hebron. Barcelona, Spain.|