Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Eastern Hepatobiliary Surgery Hospital

ClinicalTrials.gov Identifier:

NCT00825669

First received: January 16, 2009

Last updated: January 23, 2009

Last verified: January 2009

History of Changes

Purpose

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.

Condition	Intervention
Hepatocellular Carcinoma	Drug: TACE Procedure: Laser ablation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:

overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the changes of the PVTT [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: TAE Procedure: Laser ablation Laser ablation is given to the PVTT. Other Name: Microinvasive

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825669

Contacts

Contact: lu zhenghua, M.D	0086-02125070736	lu_zhenghua@126.com
Contact: xu aiming, M.D	oo86-02125074931

Locations

China, Shanghai
Eastern Hepatobiliary Surgery Hospital	Recruiting
Shanghai, Shanghai, China, 200438
Contact: Zhenghua Lu, M.D. 0086-021-25070736 lu_zhenghua@126.com

Sponsors and Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

Study Chair:

shen feng, M.D

Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

More Information

No publications provided

Responsible Party:	Lu Zhenghua, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:	NCT00825669 History of Changes
Other Study ID Numbers:	EHBH-RCT-2008-015
Study First Received:	January 16, 2009
Last Updated:	January 23, 2009
Health Authority:	China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:

hepatocellular carcinoma
Portal vein tumor thrombus
laser ablation

Additional relevant MeSH terms:

Carcinoma
Thrombosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases

Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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