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

NCT01470547 | Completed DMC

• 1 other identifier: SIMI PRO-LIVER
• Study Type: observational
• Target: 753
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Cirrhosis; Portal Vein Thrombosis

Keywords

Liver Cirrhosis; Portal Vein Thrombosis; Cirrhosis Complications; Registry; Italian

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Thrombotic Events

  2 years

• Mortality

  2 Years

• Cirrhosis Complications

  2 Years

• Bleeding

  2-4 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver cirrhosis patients

You may qualify if:

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

You may not qualify if:

• Extrahepatic neoplasms

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Pavia: collaborator

Study Sites (2)

Sapienza - University of Rome

Rome, RM, 00161, Italy

Location

Società Italiana di Medicina Interna

Rome, RM, 00161, Italy

Location

Related Publications (2)

• D'Amico T, Miglionico M, Cangemi R, Romiti GF, De Fabrizio B, Fasano S, Recchia F, Stefanini L, Raparelli V, Violi F, Basili S; P. R. O.-LIVER Collaborators. Neutrophil-lymphocyte ratio is associated with worse outcomes in patients with cirrhosis: insights from the PRO-LIVER Registry. Intern Emerg Med. 2025 Aug;20(5):1371-1380. doi: 10.1007/s11739-025-03955-x. Epub 2025 May 20.

  PMID: 40392481 DERIVED

• 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.

  PMID: 27026379 DERIVED

Related Links

• Società Italiana di Medicina Interna
• Preliminary data

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples (in ancillary study)

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Violi, MD

  Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMI

  STUDY CHAIR

• Gino R Corrazza, MD

  Fondazione IRCCS Policlinico San Matteo and SIMI

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: April 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)