Swiss Liver Venous Thrombosis Study (SLVTS-SASL-35)

March 14, 2023 updated by: University Hospital Inselspital, Berne

A Multicenter Prospective Observational Cohort Study

The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at collecting clinical data, patient reported outcomes and biological samples of all patients who have been newly and previously diagnosed with liver venous thrombosis in one of the participating hospitals in- and out-patient clinics of the participating centers in Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are currently being treated in one of the participating centers, will be asked to participate in the study.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background

Outcome measures:

Primary: Liver venous thrombosis recanalization

Secondary: Thrombosis progression, Overall mortality, Major bleeding, Ascites

Objective

  • To start a prospective observational cohort study of Liver Venous Thrombosis patients in Switzerland from their primary diagnosis and already diagnosed patients.
  • To examine long-term medical outcomes in patients with liver venous thrombosis in Switzerland by defining incidence, risk factors and treatment results
  • To prospectively collect data on medical history, serious comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and complications.
  • To store in a biobank blood and biological samples, obtained during routine practice

Methods

N/A

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Baden, Switzerland, 5404
        • Recruiting
        • Medizinische Klinik - Kantonsspital Baden
      • Geneva, Switzerland, 1211
        • Not yet recruiting
        • Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois
      • Lugano, Switzerland, 6900
        • Recruiting
        • Centro di Epatologia - Clinica Luganese Moncucco
      • St. Gallen, Switzerland, 9007
        • Recruiting
        • Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen
      • Zürich, Switzerland, 8091
        • Recruiting
        • Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich
    • Kanton Basel
      • Basel, Kanton Basel, Switzerland, 4031
        • Recruiting
        • Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel
    • Kanton Bern
      • Bern, Kanton Bern, Switzerland, 3010
        • Recruiting
        • Department of Clinical Research, Hepatology Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Liver Venous Thrombosis patients in participating hospitals in Switzerland

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Admitted in hospital or attend outpatient clinic
  • Objectively confirmed portal vein thrombosis and/or hepatic vein thrombosis
  • Budd-Chiari-Syndrome (BCS), Non-Cirrhotic Intrahepatic Portal Hypertension (NCIPH), Sinusoidal Obstructive Syndrome (SOS), Other Vascular Diseases (Hepatoportal Sclerosis (HC), Nodular Regenerative Hyperplasia (NRH), Obliterative Portal Venopathy (OPV) or Idiopathic Portal Hypertension (IPH))
  • Subjects willing to provide informed consent

Exclusion Criteria

  • Thrombosis limited to mesenteric or splenic vein
  • Inability to sign consent form
  • Follow-up not possible
  • Cardiovascular, tumoral, pulmonary comorbidity with life expectancy estimated to be less than 6 months
  • Portal vein invasion by hepatocellular carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Liver Venous Thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with liver venous thrombosis recanalization
Time Frame: End of study, expected to be on average after 5 years
End of study, expected to be on average after 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patient with thrombosis recurrence and progression
Time Frame: End of study, expected to be on average after 5 years
End of study, expected to be on average after 5 years
Overall mortality
Time Frame: End of study, expected to be on average after 5 years
End of study, expected to be on average after 5 years
Number of patients with major bleeding
Time Frame: End of study, expected to be on average after 5 years
End of study, expected to be on average after 5 years
Number of patients with ascites
Time Frame: End of study, expected to be on average after 5 years
End of study, expected to be on average after 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Foundation for Liver Research

Investigators

  • Principal Investigator: Andrea De Gottardi, Prof. Dr. med., Inselspital (University Hospital) Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2014

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SLVTS-SASL-35

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 Observational Study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe