Follow up After TACE by Elastography and Color Doppler.

NCT ID: NCT06070623

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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}.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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US

We use elastography and color Doppler from US machine and compare results with CT

Intervention Type DEVICE

Other Intervention Names

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CT

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Marco Moheb Samaan Drota

Dr at diagnostic and interventional radiology department - South Egypt cancer institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa Thabet, Prof Dr

Role: STUDY_DIRECTOR

Professor doctor at radiology department - Assiut University

Haysam Samy, Prof Dr

Role: STUDY_DIRECTOR

Professor doctor at radiology department - South Egypt cancer institute

Mohamed Elbaroudy, Ass. Prof Dr

Role: STUDY_DIRECTOR

Assistant professor doctor at radiology department - South Egypt cancer institute

Central Contacts

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Marco Drota, Radiologist

Role: CONTACT

+201060134725

References

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Tierney J, Baker J, Borgmann A, Brown D, Byram B. Non-contrast power Doppler ultrasound imaging for early assessment of trans-arterial chemoembolization of liver tumors. Sci Rep. 2019 Sep 10;9(1):13020. doi: 10.1038/s41598-019-49448-8.

Reference Type BACKGROUND
PMID: 31506503 (View on PubMed)

Sato Y, Watanabe H, Sone M, Onaya H, Sakamoto N, Osuga K, Takahashi M, Arai Y; Japan Interventional Radiology in Oncology Study Group-JIVROSG. Tumor response evaluation criteria for HCC (hepatocellular carcinoma) treated using TACE (transcatheter arterial chemoembolization): RECIST (response evaluation criteria in solid tumors) version 1.1 and mRECIST (modified RECIST): JIVROSG-0602. Ups J Med Sci. 2013 Mar;118(1):16-22. doi: 10.3109/03009734.2012.729104. Epub 2012 Nov 20.

Reference Type BACKGROUND
PMID: 23167460 (View on PubMed)

Hou S, Hua S, Cui K, Liu F, Ding K, Yuan J. The course and prognostic value of tumor stiffness detected by ultrasound elastography for transarterial chemoembolization of hepatocellular carcinoma. Quant Imaging Med Surg. 2023 Jun 1;13(6):3962-3972. doi: 10.21037/qims-22-292. Epub 2023 May 9.

Reference Type BACKGROUND
PMID: 37284088 (View on PubMed)

Conti CB, Cavalcoli F, Fraquelli M, Conte D, Massironi S. Ultrasound elastographic techniques in focal liver lesions. World J Gastroenterol. 2016 Mar 7;22(9):2647-56. doi: 10.3748/wjg.v22.i9.2647.

Reference Type BACKGROUND
PMID: 26973405 (View on PubMed)

Other Identifiers

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Elastography, Doppler in TACE.

Identifier Type: -

Identifier Source: org_study_id

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