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

NCT02692430 | Unknown

• 1 other identifier: LIVIMIAGE-129
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Portal Hypertension; Hepatic Encephalopathy

Keywords

Portosystemic Shunt; Hepatic encephalopathy; Portal hypertension; Liver cirrhosis

Outcome Measures

Primary Outcomes (2)

• Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI

  4 years

• Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation

  4 years

Secondary Outcomes (2)

• Type of portosystemic shunts detected by angio-CT scan or MRI

  4 years

• Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome)

  4 years

Interventions

No intervention is studied OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• IRCCS Policlinico S. Donato: collaborator
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Odense University Hospital: collaborator
• Puerta de Hierro University Hospital: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• University of Alberta: collaborator
• University Hospital, Bonn: collaborator
• University Hospital, Gasthuisberg: collaborator
• Vienna General Hospital: collaborator

Study Sites (1)

Vall d'Hebron Hospital

Barcelona, Spain

Location

Related Publications (5)

• Riggio O, Efrati C, Catalano C, Pediconi F, Mecarelli O, Accornero N, Nicolao F, Angeloni S, Masini A, Ridola L, Attili AF, Merli M. High prevalence of spontaneous portal-systemic shunts in persistent hepatic encephalopathy: a case-control study. Hepatology. 2005 Nov;42(5):1158-65. doi: 10.1002/hep.20905.

  PMID: 16250033 BACKGROUND

• Laleman W, Simon-Talero M, Maleux G, Perez M, Ameloot K, Soriano G, Villalba J, Garcia-Pagan JC, Barrufet M, Jalan R, Brookes J, Thalassinos E, Burroughs AK, Cordoba J, Nevens F; EASL-CLIF-Consortium. Embolization of large spontaneous portosystemic shunts for refractory hepatic encephalopathy: a multicenter survey on safety and efficacy. Hepatology. 2013 Jun;57(6):2448-57. doi: 10.1002/hep.26314. Epub 2013 May 1.

  PMID: 23401201 BACKGROUND

• Uflacker R, Silva Ade O, d'Albuquerque LA, Piske RL, Mourao GS. Chronic portosystemic encephalopathy: embolization of portosystemic shunts. Radiology. 1987 Dec;165(3):721-5. doi: 10.1148/radiology.165.3.3685350.

  PMID: 3685350 BACKGROUND

• Ohnishi K, Sato S, Saito M, Terabayashi H, Nakayama T, Saito M, Chin N, Iida S, Nomura F, Okuda K. Clinical and portal hemodynamic features in cirrhotic patients having a large spontaneous splenorenal and/or gastrorenal shunt. Am J Gastroenterol. 1986 Jun;81(6):450-5.

  PMID: 3518409 BACKGROUND

• Simon-Talero M, Roccarina D, Martinez J, Lampichler K, Baiges A, Low G, Llop E, Praktiknjo M, Maurer MH, Zipprich A, Triolo M, Vangrinsven G, Garcia-Martinez R, Dam A, Majumdar A, Picon C, Toth D, Darnell A, Abraldes JG, Lopez M, Kukuk G, Krag A, Banares R, Laleman W, La Mura V, Ripoll C, Berzigotti A, Trebicka J, Calleja JL, Tandon P, Hernandez-Gea V, Reiberger T, Albillos A, Tsochatzis EA, Augustin S, Genesca J; Baveno VI-SPSS group from the Baveno Cooperation. Association Between Portosystemic Shunts and Increased Complications and Mortality in Patients With Cirrhosis. Gastroenterology. 2018 May;154(6):1694-1705.e4. doi: 10.1053/j.gastro.2018.01.028. Epub 2018 Jan 31.

  PMID: 29360462 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joan Genesca, MD

  Vall d´Hebron Research Institut. Hospital Vall d´Hebron. Barcelona, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 26, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 31, 2017

Record last verified: 2016-10

Locations

ES (1)