Clinical trial NCT02692430: The International Imaging Registry in Liver Cirrhosis (BAVENO-VI SPSS GROUP).
Official title: LARGE SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSSs) IN PATIENTS WITH LIVER CIRRHOSIS. CLINICAL AND RADIOLOGICAL CHARACTERISTICS.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Portal Hypertension
Hepatic Encephalopathy
Keywords: Portosystemic Shunt
Hepatic encephalopathy
Portal hypertension
Liver cirrhosis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: IRCCS Policlinico S. Donato
name: Martin-Luther-Universität Halle-Wittenberg
name: Hospital Clinic of Barcelona
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario Ramon y Cajal
name: Odense University Hospital
name: Puerta de Hierro University Hospital
name: Royal Free Hospital NHS Foundation Trust
name: University of Alberta
name: University Hospital, Bonn
name: University Hospital, Gasthuisberg
name: Vienna General Hospital
First posted: 2016-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI
timeFrame: 4 years
measure: Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation
timeFrame: 4 years
Secondary outcomes:
measure: Type of portosystemic shunts detected by angio-CT scan or MRI
timeFrame: 4 years
measure: Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome)
timeFrame: 4 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
Study officials:
affiliation: Vall d´Hebron Research Institut. Hospital Vall d´Hebron. Barcelona, Spain.
name: Joan Genesca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.