Clinical trial NCT06070623: Follow up After TACE by Elastography and Color Doppler.
Official title: Role of Sonograpic Evaluation Via Doppler and Elastography in Evaluation of Hepatic Neoplasms Post TACE With Correlation With Modified RECIST Criteria.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: TACE
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatic focal lesion , which is eligable to trans arterial chemoebmolization.

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

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}.

Eligibility criteria: 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.

Primary outcomes:
measure: Role of elastography and color Doppler to follow up after TACE.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor doctor at radiology department - Assiut University
name: Mostafa Thabet, Prof Dr
role: STUDY_DIRECTOR
affiliation: Professor doctor at radiology department - South Egypt cancer institute
name: Haysam Samy, Prof Dr
role: STUDY_DIRECTOR
affiliation: Assistant professor doctor at radiology department - South Egypt cancer institute
name: Mohamed Elbaroudy, Ass. Prof Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.