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NCT Number: NCT06089785

Elastography in Liver Cell Failure

1. evaluation of degree of spleen stiffness in liver cell failure patient by elastography. 2. correlation of degree of spleen stiffness and patient outcome

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, Egypt

About this study

Portal hypertension (PH) is a major complication of liver cirrhosis, as it predisposes to the development of serious clinical manifestations such as ascites, hepatic encephalopathy and variceal bleeding, aggravating the prognosis of patients.

Liver biopsy and hepatic venous pressure gradient (HVPG) measurements are the current gold standard procedures for determining fibrosis severity and diagnosing PH, respectively; however, both are invasive, limiting their use in clinical practice and larger trials of novel agents. Alternatively, many non-invasive methods have been proposed in order to substitute HVPG. Alterations in the biomechanical properties of the liver or spleen in patients with cirrhosis can be quantified by tissue elastography, which examines the elastic behavior of tissue after a force has been applied Among them, liver stiffness measurement (LSM) has been widely used, as it has been shown to correlate well with HVPG, though this relationship seems to weaken in values of HVPG higher than 12 mmHg, the threshold of serious complications development. Several studies supported the use of spleen stiffness measurement (SSM) instead of LSM, anticipating to a more adequate assessment of this advanced stage of PH. SS measured by ultrasound-based elastography showed good correlation with HVPG, detecting PH with a sensitivity and specificity of 0.88 and 0.92, respectively, and severe PH with a sensitivity and specificity of 0.92 and 0.79, respectively.The aim of this paper is to critically appraise and summarize the literature about the role of SSM as a predictive tool of liver decompensation and prognosis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1- Age above 18 years. 2-patients with liver cell failure (hepatic encephalopathy, hematemesis, ascites, hepatocellular carcinoma) 3- patient height , Weight

Exclusion criteria

  • 1- patients who refuse to contribute in this study. 2- Age below 18 years. 3-pregnancy and breastfeeding.

Treatment and study plan

Elastography

Device

evaluation of degree of spleen stiffness in liver cell failure patient by elastography.

Primary outcomes

  1. Evaluation of splenic stiffness in liver cell failure patients: role of elastography

    Time frame: 4 years

    • evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
    • correlation of degree of spleen stiffness and patient outcome

Study contacts

Contact information is provided by the study sponsor or research team.

omnia saad

CONTACT

[email protected]

010049763

sohier mostafa

CONTACT

[email protected]

01069347314

Sponsors and collaborators

Lead sponsor

Omnia Saad Desoky Mohamed

Other

Registry information

Official study title

Evaluation of Splenic Stiffness in Liver Cell Failure Patients:Role of Elastography

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.