Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00825669

Enrollment

100

Registered

2009-01-21

Start date

2008-12-31

Completion date

2010-12-31

Last updated

2016-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, Portal vein tumor thrombus, laser ablation

Brief summary

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

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.

Interventions

DRUGTACE

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.

PROCEDURELaser ablation

Laser ablation is given to the PVTT.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
overall survival	2010

Secondary

Measure	Time frame
the changes of the PVTT	2010

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026