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

• Conditions: Hepatic Encephalopathy; Liver Cirrhosis; Portal Hypertension

• Registration Number: NCT02692430
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-07-31
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation	4 years
Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI	4 years

Secondary Outcome Measures

Name	Time	Method
Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome)	4 years
Type of portosystemic shunts detected by angio-CT scan or MRI	4 years

Trial Locations

Locations (1)

Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain