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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02692430
• Other study ID #: LIVIMIAGE-129
• Status: Active, not recruiting
• Phase: N/A
• First received: February 10, 2016
• Last updated: July 28, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Encephalopathy
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Other:
• No intervention is studied

Locations

Country	Name	City	State
Spain	Vall d'Hebron Hospital	Barcelona

Sponsors (13)

Lead Sponsor

Collaborator

Hospital Universitari Vall d'Hebron Research Institute

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

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Uflacker R, Silva Ade O, d'Albuquerque LA, Piske RL, Mourão GS. Chronic portosystemic encephalopathy: embolization of portosystemic shunts. Radiology. 1987 Dec;165(3):721-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI		4 years
Primary	Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation		4 years
Secondary	Type of portosystemic shunts detected by angio-CT scan or MRI		4 years
Secondary	Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome)		4 years