Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

Study Overview
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Brief Summary
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Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.

Detailed Description
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Hepatectomy is still the treatment of choice for hepatocellular carcinoma, but the prognosis is not agreeable. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might further increase the pressure of portal vein and lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment available now for PVTT yet. TACE is mostly often used to treat the PVTT. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.

Official Title
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A Randomized Controlled Trial of Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: TACE
* Procedure: Laser ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PVTT after liver resection was diagnosed with at least two types of imaging findings, such as CT, MRI or color doplor findings. The functions of the kidney, heart and lung and the routine test of the blood are in good condition. The liver function is of grade A or B in Child-Pugh classification. The patient is eligible of the trial and will show consent to the test. Exclusion Criteria: any of the parameters. WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml. disfunction of the heart, lung, kidney, or brain. any other disease might affect the trial . the patients would not sign the consent to the trial.

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: survival rate (TACE)<br>to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT | Drug: TACE<br>* TACE: The chemotherapeutic drugs and 2 to 10 ml lipiodol are given via hepatica propria artery. The chemotherapeutic drugs include 5-Fu 1500 mg, epirubicin 30 mg, cisplatin 30 mg.<br>* Other names: TAE;|
| Active Comparator: survival rate (TACE plus laser ablation)<br>to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT | Drug: TACE<br>* TACE: The chemotherapeutic drugs and 2 to 10 ml lipiodol are given via hepatica propria artery. The chemotherapeutic drugs include 5-Fu 1500 mg, epirubicin 30 mg, cisplatin 30 mg.<br>* Other names: TAE;Procedure: Laser ablation<br>* Laser ablation is given to the PVTT.<br>* Other names: Microinvasive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of the PVTT |  | 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, Portal vein tumor thrombus, laser ablation