Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry
Condition: Liver Cirrhosis; Portal Vein Thrombosis
MeSH terms: Liver Cirrhosis; Thrombosis; Venous Thrombosis; Fibrosis
Study type: Observational

Summary: 
      The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC),
      neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory
      diseases, trauma and surgery. LC is an important predisposing disease and is responsible for
      about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient.

      Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can
      occur in approximately 10% of cirrhotic patients.

      Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study
      in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was
      present in 15.7% of patients, a higher percentage was found in patients with liver cancer
      (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less
      frequently complicated by PVT.

      The PVT development is due to stagnation in the portal circulation, but alterations in the
      sense of inherited or acquired pro-coagulant may favor its appearance.

      The causal association of PVT with bleeding and bowel infarction suggests that the PVT may
      reduce survival in cirrhosis, but data are lacking on this issue. It is also not known
      whether asymptomatic patients with PVT have a different survival compared to cirrhotic
      patients without PVT. Further studies should be conducted to clarify this issue.

      Likewise, prospective studies are needed to better identify risk factors predisposing to PVT
      in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The
      impact of PVT on the natural history of cirrhosis is an issue today still debated.

      The PVT not only favour life-threatening complications (gastrointestinal bleeding and
      mesenteric thrombosis) but could also contribute to a deterioration of liver function by
      reducing portal flow. Obtaining such information would be of crucial importance considering
      that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the
      need for randomized controlled trials to clarify the potential effectiveness of anticoagulant
      therapy to improve the survival.

      To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In
      the second phase of the project is planned a 2-years follow-up program in order to assess
      whether the PVT be an additional risk factor for mortality or deterioration of the natural
      history in patients with cirrhosis.
    

Detailed description: 
      Study Design: Prospective Longitudinal Study.

      The investigators planned to assess at baseline and at scheduled follow up visits:

        -  Medical history collection with thrombosis risk factors evaluation;

        -  Clinical parameters collection;

        -  Upper abdomen ultrasound and portal district echo color doppler to evaluate the presence
           of PVT;

        -  Esophagogastroduodenoscopy;

        -  Routine blood samples collection with plasma and urine storage;

      At every follow up visit will be evaluated all relevant clinical events and will be recorded
      all treatments received during the follow-up period.

      Sample Size: The investigators plan to include in the study n = 1100 patients. The sample
      size was calculated assuming an expected prevalence of 18% at time zero, and in order to
      obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less
      than or equal to 3%.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Liver cirrhosis patients
      
Biospecimen description: 
      Plasma and serum samples (in ancillary study)
    
Keywords: Liver Cirrhosis; Portal Vein Thrombosis; Cirrhosis Complications; Registry; Italian