- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02692430
The International Imaging Registry in Liver Cirrhosis (BAVENO-VI SPSS GROUP).
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain
- Vall d'Hebron Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Joan Genesca, MD, Vall d´Hebron Research Institut. Hospital Vall d´Hebron. Barcelona, Spain.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Liver Diseases
- Brain Diseases, Metabolic
- Fibrosis
- Hypertension
- Liver Cirrhosis
- Hepatic Encephalopathy
- Brain Diseases
- Hypertension, Portal
Other Study ID Numbers
- LIVIMIAGE-129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Liver Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
The Second Affiliated Hospital of Chongqing Medical...RecruitingFibrosis, Liver | Cirrhosis, LiverChina
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
The Cleveland ClinicRecruiting
-
The Cleveland ClinicRecruitingCirrhosis, LiverUnited States
-
University of PittsburghNational Institute on Drug Abuse (NIDA)CompletedCirrhosis, LiverUnited States
-
Beth Israel Deaconess Medical CenterAmerican Association for the Study of Liver Diseases FoundationCompleted
-
Asian Institute of Gastroenterology, IndiaCompletedCirrhosis, LiverIndia
-
Sherief Abd-ElsalamUnknown
Clinical Trials on No intervention is studied
-
University of Dublin, Trinity CollegeCompleted
-
Washington University School of MedicineCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
University Hospital A CoruñaNot yet recruitingCritical Illness | Hematological Diseases
-
Poitiers University HospitalRecruitingMeningococcal InfectionsFrance
-
University of Alabama at BirminghamRecruiting
-
Children's National Research InstituteRecruitingEnd Stage Renal DiseaseUnited States
-
Stanford UniversityNational Institute of Allergy and Infectious Diseases (NIAID); Food Allergy...Recruiting
-
Les Toises - Psychiatry and Psychotherapy CenterCompletedDepressive Disorder | Bipolar Disorder | Bipolar DepressionSwitzerland
-
Gulhane School of MedicineCompleted
-
University of LjubljanaCompletedAthletic Injuries | Injuries | Psychological | Physical Stress | Physical Trauma | Social Stress | Physical Injury | Physical Illness | Illness, Chronic | Illnesses Systemic | Illnesses, OccupationalSlovenia