Clinical trial NCT01470547: Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry
Official title: Portal Vein Thrombosis Relevance On Liver Cirrhosis: Italian Venous Thrombotic Events Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Portal Vein Thrombosis
Keywords: Liver Cirrhosis
Portal Vein Thrombosis
Cirrhosis Complications
Registry
Italian
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2011-11-11
Enrollment: 753
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver cirrhosis patients

Brief 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%.

Eligibility criteria: Inclusion Criteria:

* Cirrhosis of any etiology and severity (including HCC)
* Signed Written Informed Consent

Exclusion Criteria:

* Extrahepatic neoplasms

Primary outcomes:
measure: PVT prevalence
timeFrame: 1 year
Secondary outcomes:
measure: Thrombotic Events
timeFrame: 2 years
measure: Mortality
timeFrame: 2 Years
measure: Cirrhosis Complications
timeFrame: 2 Years
measure: Bleeding
timeFrame: 2-4 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza - University of Rome
state: RM
city: Rome
country: Italy
facility: Società Italiana di Medicina Interna
state: RM
Study officials:
affiliation: Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMI
name: Francesco Violi, MD
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Policlinico San Matteo and SIMI
name: Gino R Corrazza, MD
role: STUDY_CHAIR
References:
citation: Violi F, Corazza GR, Caldwell SH, Perticone F, Gatta A, Angelico M, Farcomeni A, Masotti M, Napoleone L, Vestri A, Raparelli V, Basili S; PRO-LIVER Collaborators. Portal vein thrombosis relevance on liver cirrhosis: Italian Venous Thrombotic Events Registry. Intern Emerg Med. 2016 Dec;11(8):1059-1066. doi: 10.1007/s11739-016-1416-8. Epub 2016 Mar 30.