Back to resultsTreatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE
Laser ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, Portal vein tumor thrombus, laser ablation
Eligibility Criteria
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.
Sites / Locations
- Eastern Hepatobiliary Surgery Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
survival rate (TACE)
survival rate (TACE plus laser ablation)
Arm Description
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
the changes of the PVTT
Full Information
NCT ID
NCT00825669
First Posted
January 16, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00825669
Brief Title
Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
Official Title
A Randomized Controlled Trial of Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, Portal vein tumor thrombus, laser ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
survival rate (TACE)
Arm Type
Active Comparator
Arm Description
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
Arm Title
survival rate (TACE plus laser ablation)
Arm Type
Active Comparator
Arm Description
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
Intervention Type
Drug
Intervention Name(s)
TACE
Other Intervention Name(s)
TAE
Intervention Description
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
Procedure
Intervention Name(s)
Laser ablation
Other Intervention Name(s)
Microinvasive
Intervention Description
Laser ablation is given to the PVTT.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2010
Secondary Outcome Measure Information:
Title
the changes of the PVTT
Time Frame
2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shen feng, M.D
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Learn more about this trial
Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
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