Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma.

Detailed Description
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To compare between combination treatment with radiofrequency or microwave ablation followed by transarterial chemoembolization and performed in a single session.

Official Title
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Comparison of Single Session Transarterial Chemoembolization Combined With Microwave Ablation or Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: Transarterial chemoembolization (TACE)
* Procedure: Radiofrequency ablation combined with TACE
* Procedure: Microwave ablation combined with TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child classification A or B. serum albumin ≥ 3 gm/L. serum bilirubin < 2.5 mg/dL. platelet count ≥70,000 mm3. INR ≤ 1.6. serum creatinine < 2 mg/dl. tumor size more than 4 cm and confined to one lobe of the liver. Exclusion Criteria: Patients with portal vein thrombosis. A technically inaccessible hepatic artery. Metastatic HCC. More than three lesions. lesions in close proximity to the portal vein (PV),inferior vena cava (IVC) or gall bladder were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transarterial chemoembolization (TACE)<br>treated by transarterial chemoembolization | Drug: Transarterial chemoembolization (TACE)<br>* TACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles<br>* Other names: Transarterial chemoembolization;|
| Experimental: Radiofrequency ablation with TACE<br>Radiofrequency ablation combined with TACE | Procedure: Radiofrequency ablation combined with TACE<br>* Radiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition<br>|
| Experimental: Microwave ablation combined with TACE<br>Microwave ablation combined with TACE. | Procedure: Microwave ablation combined with TACE<br>* Microwave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful ablation | The total number of patients with successful ablation | 3 months |