NCT07560202

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Portal vein thrombosisliver cirrhosisD-dimer

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Portal Vein Thrombosis (PVT)

    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

    Identification of clinical, laboratory, and radiological factors associated with the presence of PVT in cirrhotic patients

    Baseline assessment

Secondary Outcomes (2)

  • Radiological Pattern of PVT

    At time of PVT diagnosis

  • Association Between PVT Type and Clinical Parameters

    At time of diagnosis

Study Arms (1)

Group 1 (Patients): with PVT, Group 2 (Controls): without PVT

Diagnostic Test: Abdominal US, Doppler US and abdominal multi-slice computed tomography (MSCT) with contrast was performed

Interventions

to assess portal circulation, portosystemic collaterals, the presence of PVT, ascites and HCC.

Group 1 (Patients): with PVT, Group 2 (Controls): without PVT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with liver cirrhosis

You may qualify if:

  • Adult patients with liver cirrhosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Gastroenterology and Tropical Medicine

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

June 1, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

I do not have specific consent from participants to share individual-level data.

Locations