Evaluation of Liver Stiffness by Ultrasound Elastography for Predicting Early HCC Recurrence After Treatment

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04552236
• Lead Sponsor: Assiut University

Brief Summary

We aim to evaluate liver stiffness as a marker of severity and duration of the underlying liver disease to predict for early HCC recurrence after treatment.

Detailed Description

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide and contributes to enormous cancer-related deaths annually . Hepatocellular carcinoma is a frequent complication of liver disease. Early recurrence is mainly tumour or treatment-related .

Liver fibrosis stagging is essential to evaluate the expected prognosis against the concomitant therapies. Liver biopsy remain the gold standard for diagnosing liver fibrosis, however, it is limited due to the associated costs, invasiveness, and intra and inter observer variability. Patient discomfort, refusal and risk of complications. Ultrasound Elastography is a non-invasive imaging method liver fibrosis staging . Ultrasound Elastography is an imaging technology sensitive to tissue stiffness that was developed in the 1990s. It has been further developed and refined in recent years to enable quantitative assessment of tissue stiffness. Elastography methods take advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes .

Elastography is an application, which produces the force coupled with a measurement system for the deformities caused by the force. There are several types of forces: 1. static compression induced externally by manual compression or internally by organ motion (heart, vessel, and breathing) 2. Dynamic compression induced with a continuous vibration at a given frequency 3. Impulse compression (transient vibration) induced externally by a transient mechanical impulse ( Fibroscan) or internally by an ultrasound impulse (ARFI, SWE), both compression types producing shear waves. While contrast-enhanced imaging is the first-line approach in the diagnosis of HCC, recent report show that the non-invasively measured stiffness of hepatic nodule could help to distinguish between malignant and benign liver lesions.

The treatment of HCC depends on the stage of liver disease and in many cases, curative resection is not possible. Therefore local ablative therapies, such as transarterial chemoembolization (TACE) and radiofrequency ablation (RFA), are considered viable therapeutic options . However, HCC might behave very differently and could show more or less of a response to local ablative treatment

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17
• Study Start: 2021-01
• Primary Completion: 2022-01
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients with liver cirrhosis and HCC.

Exclusion Criteria

• Metastatic hepatic focal lesions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predicting early HCC recurrence after treatment by Ultrasound elastography	Baseline	TO enhance surveillance and detect HCC recurrence as early as possible for further management