- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560202
Portal Vein Thrombosis in Liver Cirrhosis: Clinical Characteristics, Radiological Patterns, and Predictors (Thrombosis)
Portal vein thrombosis (PVT) is a common complication in patients with liver cirrhosis and is associated with increased morbidity due to worsening portal hypertension and hepatic decompensation. The clinical presentation and radiological patterns of PVT vary widely, and the factors predicting its development remain incompletely understood.
This observational study will include adult patients (≥18 years) with established liver cirrhosis who are admitted to the Department of Gastroenterology and Tropical Medicine, Al-Rajhi Liver Hospital, Assiut University. Eligible participants will undergo routine screening for PVT using Doppler ultrasonography, with confirmation by contrast-enhanced computed tomography when indicated.
The study aims to evaluate the clinical characteristics, laboratory parameters, and radiological features of PVT. Cases of PVT will be classified according to extent (partial or complete) and anatomical location (main portal vein, right branch, left branch, or combined involvement). Clinical and laboratory data will be analyzed to identify potential predictors associated with the development and severity of PVT.
The findings of this study are expected to improve understanding of the risk factors and radiological patterns of PVT in cirrhotic patients, contributing to better risk stratification and clinical management.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Asyut, Egypt, 71515
- Assiut University Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients with liver cirrhosis
Exclusion Criteria:
- Patients with non-hepatic hemostatic disorders, active bacterial sepsis, renal dysfunction, peripheral or hepatic venous thrombosis, recent splenectomy, liver transplantation, antiplatelet or anticoagulant therapy or contraceptive pills were excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1 (Patients): with PVT, Group 2 (Controls): without PVT
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to assess portal circulation, portosystemic collaterals, the presence of PVT, ascites and HCC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Portal Vein Thrombosis (PVT)
Time Frame: At baseline (during study enrollment period)
|
Proportion of cirrhotic patients diagnosed with portal vein thrombosis based on Doppler ultrasonography with confirmation by contrast-enhanced CT when indicated.
|
At baseline (during study enrollment period)
|
|
Predictors of Portal Vein Thrombosis
Time Frame: Baseline assessment
|
Identification of clinical, laboratory, and radiological factors associated with the presence of PVT in cirrhotic patients
|
Baseline assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiological Pattern of PVT
Time Frame: At time of PVT diagnosis
|
Distribution of portal vein thrombosis according to: Extent (partial vs complete) Anatomical location (main portal vein, right branch, left branch, or combined involvement) |
At time of PVT diagnosis
|
|
Association Between PVT Type and Clinical Parameters
Time Frame: At time of diagnosis
|
Correlation between type of PVT (partial vs complete) and clinical/laboratory characteristics of patients.
|
At time of diagnosis
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUN-PVT-LC-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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