Elastography in Liver Cell Failure

Not yet recruiting

• Conditions: Liver Cell Damage
• Interventions: Device: elastography

• Registration Number: NCT06089785
• Lead Sponsor: Omnia Saad Desoky Mohamed

Brief Summary

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

2. correlation of degree of spleen stiffness and patient outcome

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-09-29
• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with liver cell failure	elastography	patients with liver cell failure and any complications

Primary Outcome Measures

Name	Time	Method
Evaluation of splenic stiffness in liver cell failure patients: role of elastography	4 years	1. evaluation of degree of spleen stiffness in liver cell failure patient by elastography.; 2. correlation of degree of spleen stiffness and patient outcome

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt