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OpenTrials
Completed

NCT Number: NCT00825669

Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TACE

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.

Other names: TAE

Laser ablation

Procedure

Laser ablation is given to the PVTT.

Other names: Microinvasive

Primary outcomes

  1. overall survival

    Time frame: 2010

Secondary outcomes

  1. the changes of the PVTT

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 21, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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