Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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survival rate (TACE)

to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type DRUG

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.

survival rate (TACE plus laser ablation)

to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type DRUG

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.

Laser ablation

Intervention Type PROCEDURE

Laser ablation is given to the PVTT.

Interventions

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TACE

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.

Intervention Type DRUG

Laser ablation

Laser ablation is given to the PVTT.

Intervention Type PROCEDURE

Other Intervention Names

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TAE Microinvasive

Eligibility Criteria

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Inclusion Criteria

1. PVTT after liver resection was diagnosed with at least two types of imaging findings, such as CT, MRI or color doplor findings.
2. The functions of the kidney, heart and lung and the routine test of the blood are in good condition.
3. The liver function is of grade A or B in Child-Pugh classification.
4. The patient is eligible of the trial and will show consent to the test.

Exclusion Criteria

1. any of the parameters. WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml.
2. disfunction of the heart, lung, kidney, or brain.
3. any other disease might affect the trial .
4. the patients would not sign the consent to the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No