Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: TACE; Procedure: Laser ablation

• Registration Number: NCT00825669
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
survival rate (TACE)	TACE	to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
survival rate (TACE plus laser ablation)	TACE	to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
survival rate (TACE plus laser ablation)	Laser ablation	to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Primary Outcome Measures

Name	Time	Method
overall survival	2010

Secondary Outcome Measures

Name	Time	Method
the changes of the PVTT	2010

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China