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

July 28, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

LARGE SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSSs) IN PATIENTS WITH LIVER CIRRHOSIS. CLINICAL AND RADIOLOGICAL CHARACTERISTICS.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Vall d'Hebron Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Odense University Hospital
Hospital General Universitario Gregorio Marañon
Hospital Clinic of Barcelona
IRCCS Policlinico S. Donato
University of Alberta
University Hospital, Gasthuisberg
Royal Free Hospital NHS Foundation Trust
University Hospital, Bonn
Hospital Universitario Ramon y Cajal
Martin-Luther-Universität Halle-Wittenberg
Puerta de Hierro University Hospital
Vienna General Hospital

Investigators

  • Principal Investigator: Joan Genesca, MD, Vall d´Hebron Research Institut. Hospital Vall d´Hebron. Barcelona, Spain.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVIMIAGE-129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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