Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Randomized Controlled Trial of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern Hepatobiliary Surgery Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: survival rate (TACE)
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
Drug: 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.
Other Names:
  • TAE
ACTIVE_COMPARATOR: survival rate (TACE plus laser ablation)
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
Drug: 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.
Other Names:
  • TAE
Procedure: Laser ablation
Laser ablation is given to the PVTT.
Other Names:
  • Microinvasive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2010
2010

Secondary Outcome Measures

Outcome Measure
Time Frame
the changes of the PVTT
Time Frame: 2010
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Study Chair: shen feng, M.D, Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (ESTIMATE)

January 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBH-RCT-2008-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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