Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

NCT00825669 | Completed DMC

• 1 other identifier: EHBH-RCT-2008-015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; Portal vein tumor thrombus; laser ablation

Outcome Measures

Primary Outcomes (1)

• overall survival

  2010

Secondary Outcomes (1)

• the changes of the PVTT

  2010

Study Arms (2)

survival rate (TACE)

ACTIVE COMPARATOR

to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Drug: TACE

survival rate (TACE plus laser ablation)

ACTIVE COMPARATOR

to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Drug: TACE; Procedure: Laser ablation

Interventions

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.

Also known as: TAE

survival rate (TACE plus laser ablation); survival rate (TACE)

Laser ablation PROCEDURE

Laser ablation is given to the PVTT.

Also known as: Microinvasive

survival rate (TACE plus laser ablation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• shen feng, M.D

  Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 21, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)