Follow up After TACE by Elastography and Color Doppler.

October 2, 2023 updated by: Marco Moheb Samaan Drota, Assiut University

Role of Sonograpic Evaluation Via Doppler and Elastography in Evaluation of Hepatic Neoplasms Post TACE With Correlation With Modified RECIST Criteria.

To determine accuracy of elastography and color Doppler in follow up of patients with HCC after TACE comparing with modified RECIST criteria.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of liver cancer is one of the highest in the world. In Egypt HCC is the forth common cancer and represents up to 90% of all liver malignancies. Where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively.

Transarterial chemoembolization (TACE) is recommended as the first-line treatment in early stage patients with hepatocellular carcinoma (HCC) or as a palliative treatment modality in advanced patients with unresctable tumor which was known to increase survival rate. However, tumor control usually requires multiple TACE interventions due to the presence of residual and recurrent lesions.

Currently the Response Evaluation Criteria in Solid Tumors (RECIST) guideline was proposed as a method for measuring treatment response based on tumor shrinkage, which is a valuable measure of antitumor activity of cytotoxic drugs, Which adapted the concept of viable tumor-tumoral tissue showing uptake in arterial phase of contrast-enhanced MSCT abdomen.

Elastography can provide information about tumor stiffness to predict tumor response after TACE and detect any residual or recurrence.

We also use color Doppler in follow up to detect changes in portal pressure and hepatic artries hemodynamics of HCC patients after TACE. Mainly we search for changes in portal vein velocity {PVVel}, hepatic artery resistive index {HARI} and hepatic artery pulsitality index {HAPI}.

Study Type

Observational

Enrollment (Estimated)

54

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatic focal lesion , which is eligable to trans arterial chemoebmolization.

Description

Inclusion Criteria:

  • All patients with hepatocellular carcinoma underwent TACE in South Egypt cancer institute.

Exclusion Criteria:

  • Patients with liver metastases.
  • Patients with hepatic or perihepatic inflammations.

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
Role of elastography and color Doppler to follow up after TACE.
Time Frame: Baseline
Accuracy of elastography and color Doppler in follow up of patients with HCC who underwent TACE, compared to modified RECIST criteria.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Mostafa Thabet, Prof Dr, Professor doctor at radiology department - Assiut University
  • Study Director: Haysam Samy, Prof Dr, Professor doctor at radiology department - South Egypt cancer institute
  • Study Director: Mohamed Elbaroudy, Ass. Prof Dr, Assistant professor doctor at radiology department - South Egypt cancer institute

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 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elastography, Doppler in TACE.

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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