Clinical Trial on Liver Cirrhosis, Portal Hypertension - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Patients with cirrhosis have an endotoxemic medium due to intestinal flora changes, decreased hepatic clearance of endotoxins and transition of bacteria to mesenteric lymph nodes from intestinal barrier .Serum Von Willebrand factor (vWF) increases in a linear ratio with the intensity of endotoxemia.

Portal hypertension (PH) is a hallmark of advanced chronic liver disease (ACLD) that significantly influences the onset of liver-related complications and mortality. It can be quantified using the minimally invasive measurement of the hepatic venous pressure gradient (HVPG). Experimental research has demonstrated that ongoing dysfunction of liver sinusoidal endothelial cells (LSEC) triggers the activation of hepatic stellate cells (HSC) and leads to intrahepatic vasoconstriction, thereby contributing to PH.

Von Willebrand factor (VWF) is released by activated endothelial cells and plays a crucial role in hemostasis by facilitating the adhesion of platelets to subendothelial collagen and other platelet-adhesive proteins exposed during vascular injury. Early studies revealed that VWF levels are elevated in patients with ACLD, linking this finding to endothelial dysfunction likely caused by endotoxemia , resulting from pathological bacterial translocation. Notably, VWF antigen (VWF-Ag) has shown diagnostic potential for clinically significant PH (CSPH; defined by an HVPG ≥ 10 mmHg) and prognostic value for disease progression, even after the underlying cause has been treated.

Elevated VWF levels may help balance the fragile hemostatic system in patients with ACLD by compensating for platelet deficiencies in number and possibly function.

VWF is more than just a hemostatic protein; it serves as a marker of endothelial dysfunction in patients with cirrhosis.VWF levels can independently predict decompensation and mortality in cirrhosis patients, regardless of the stage of liver disease and severity of portal hypertension. The VWF-to-thrombocyte ratio (VITRO) score enhances the diagnostic capability of VWF alone in noninvasively detecting CSPH.In addition to predicting the risk of hepatocellular carcinoma (HCC) in cirrhosis patients, VWF levels also forecast the risk of complications following HCC resection and response to systemic therapies.

Study Type

Observational

Enrollment (Estimated)

67

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

Name: Kerolos A Sameh, Resident
Phone Number: 01280978047
Email: kerosameh752@gmail.com

Study Contact Backup

Name: Mohamed A Ramadan, Lecturer
Phone Number: 01097510010
Email: drmuhamedramadan@yahoo.com

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

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients aged 18-65 years with all stages of liver cirrhosis (compensated and decompensated)

Description

Inclusion Criteria:

adult patient >18 years
both sex male and female
all stages of liver cirrhosis (compensated and decompensated)

Exclusion Criteria:

acute liver disease
any hereditary or acquired diseases that affect VWF level.
sepsis and infections (including spontaneous bacterial peritonitis), patients with any infectious symptoms at the time of study (increasing VWF Ag levels).
active extrahepatic malignancies.
previous liver transplantation.
any medication affect VWF level.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Verify Von willebrand factor role in patients with liver cirrhosis and portal hypertension by using VWF-Ag concentation and fibroscan Time Frame: Baseline	Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

Principal Investigator: Kerolos A Sameh, Resident, Assiut University
Study Director: Mohamed A Ramadan, Lecturer, Assiut University
Study Director: Abdelhamid A Mohamed, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 15, 2024

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 16, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)