Swiss Liver Venous Thrombosis Study

NCT ID: NCT01983059

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-18

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Observational Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Liver Venous Thrombosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Liver Research

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea De Gottardi, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Inselspital (University Hospital) Bern

Locations

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Department of Clinical Research, Hepatology Research Group

Bern, Canton of Bern, Switzerland

Site Status RECRUITING

Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel

Basel, Kanton Basel, Switzerland

Site Status RECRUITING

Medizinische Klinik - Kantonsspital Baden

Baden, , Switzerland

Site Status RECRUITING

Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève

Geneva, , Switzerland

Site Status NOT_YET_RECRUITING

Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status RECRUITING

Centro di Epatologia - Clinica Luganese Moncucco

Lugano, , Switzerland

Site Status RECRUITING

Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Andrea De Gottardi, Prof. Dr. med.

Role: CONTACT

031 632 38 13

Other Identifiers

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SLVTS-SASL-35

Identifier Type: -

Identifier Source: org_study_id

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