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NCT04739501 Clinical Trial

Trans-arterial Chemoembolization in Patients With Hepatocellular Carcinoma: A Study of Different Outcomes and Their Predictive Factors

Liver Cancer Clinical Trial

Official title:
Trans-arterial Chemoembolization in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04739501
Other study ID # 0987654321
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date March 30, 2022

Study information
Verified date February 2021
Source Assiut University
Contact Amany M Ahmed
Phone 01146457697
Email mahranamany18@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Radiological response after trans arterial chemoembolization (TACE) is classified according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) to: complete response (CR) (disappearance of arterial enhancement), partial response (PR) ( at least a 30% decrease in the sum of diameters of viable enhancement), progressive disease (PD) (an increase of at least 20% in the sum of the diameters of viable enhancement, or appearance of new lesions), and stable disease (any cases that do not qualify for either partial response or progressive disease

Description:

POST-TACE response of treatment for cases of hepatocellular cancer

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: Clinical history and examination with special stress on symptoms and signs of chronic liver disease with or without evidence of hepatic decompensation e.g. the presence of ascites and with or without evidence of complications e.g. jaundice spider naevi, bleeding varices, ascites, and lower limb edema. Laboratory findings in the form of raised bilirubin and liver enzymes, impaired coagulation profile, and/or low serum albumin. Abdominal ultrasonography revealing liver cirrhosis (coarse echopattern, attenuated hepatic veins, irregular outlines, hypertrophy of caudate lobe and/or shrunken liver, presence of focal hepatic) and presence of splenomegaly, ascites, or portal vein thrombosis (PVT). Exclusion Criteria: A patient who had surgical resection or liver transplantation Patients refuse to participate Hepatic focal lesion other than HCC

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• TACE
Trans-arterial chemoembolization in patients with hepatocellular carcinoma

Locations
Country Name City State
Egypt Assiut Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post_TACE hepatic cell failure Frequency of liver cell failure in form of jaundice , coagulopathy and encephalopathy 1 year
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