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

Trans-arterial Chemoembolization in Patients With Hepatocellular Carcinoma

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

Study Overview

• Status: Unknown
• Conditions: Liver Cancer
• Intervention / Treatment: Procedure: TACE

Detailed Description

POST-TACE response of treatment for cases of hepatocellular cancer

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut
    • Contact: Amany M Mahran, Residents; Phone Number: 01146457697; Email: Mahranamany18@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with HCC with TACE

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TACE in HCC group 1; the patient did undergo tace	Procedure: TACE; Trans-arterial chemoembolization in patients with hepatocellular carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post_TACE hepatic cell failure	Frequency of liver cell failure in form of jaundice , coagulopathy and encephalopathy	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: 0987654321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No