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

September 16, 2020 updated by: Reem Mohamed Saad EL Shazly, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

100

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

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HCC and liver cirrhosis expected to visit Assiut university hospital to be treated

Description

Inclusion Criteria:

  • All patients with liver cirrhosis and HCC.

Exclusion Criteria:

  • Metastatic hepatic focal lesions.

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
Measure Description
Time Frame
Predicting early HCC recurrence after treatment by Ultrasound elastography
Time Frame: Baseline
TO enhance surveillance and detect HCC recurrence as early as possible for further management
Baseline

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultrasound Elastography in HCC

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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