Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry

Liver Cirrhosis Clinical Trial

— PRO-LIVER  

Official title:

Portal Vein Thrombosis Relevance On Liver Cirrhosis: Italian Venous Thrombotic Events Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470547
• Other study ID #: SIMI PRO-LIVER
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: March 13, 2018
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 753
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Cirrhosis of any etiology and severity (including HCC)

• Signed Written Informed Consent

Exclusion Criteria:

• Extrahepatic neoplasms

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Italy	Sapienza - University of Rome	Rome	RM
Italy	Società Italiana di Medicina Interna	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVT prevalence	To estimate the prevalence of PVT evaluated by US with power-doppler in a cohort of patients with liver cirrhosis of any etiology and severity.	1 year
Secondary	Thrombotic Events	Occurrence of thrombotic complications (deep vein and portal vein thrombosis)	2 years
Secondary	Mortality	Overall mortality in a cohort of cirrhotic patients	2 Years
Secondary	Cirrhosis Complications	Occurence of other cirrhosis-related complications (previous refractory ascites or hepatic encephalopathy; onset or progression of oesophageal varices, ascites or refractory ascites, jaundice, onset of liver cancer, infections, spontaneous bacterial peritonitis, onset of hepato-renal or hepato-pulmonary syndrome)	2 Years
Secondary	Bleeding	Occurrence of digestive or other mjor or minor bleeding events in relation to platelet count and/or PT-INR	2-4 years

External Links

•   Preliminary data
•   Società Italiana di Medicina Interna