A prospective randomized trial comparing surgery therapy versus radiotherapy combined with transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with portal vein invasio
Not Applicable
Completed
- Conditions
- Cancer - LiverSurgery - Surgical techniquesconfirm the beneficial role of surgery therapy or three-dimensional conformal radiotherapy (3D-CRT) on hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT)
- Registration Number
- ACTRN12612000751875
- Lead Sponsor
- Eastern Hepatobiliary Surgery Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
1. resectable HCC with PVTT; 2. there was no previous treatment; 3.there were no other malignancies; 4. compensated cirrhosis with Child-Pugh class A, or B; 5. there were no tumor invasion of hepatic vein, bile duct,inferior vena cava; 6.there was no extrahepatic metastasis; 7.patients had no serious associated medical diseases;8. Understanding and being willing to sign the informed consent form
Exclusion Criteria
1.cannot be follow-up 2.severe liver, renal, or brain dysfunction; 3. with tumor thrombi in the hepatic vein 4.with extrahepatic metastasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the 1-, 2- and 3-year overall survival rate in surgery therapy (experimental group) versus radiology group(control group) for HCC.All patients were followed-up by one team of doctors to get the information of their survival.[Once a year from 1-3 years postoperation]
- Secondary Outcome Measures
Name Time Method Complications including postoperative hemmorrhage,bile leak ,wound infection ,etc.<br>Postoperative complications were monitored, assessed and treated by one team of doctors.[after surgery in one month];Serum alpha fetoprotein(AFP) assay will be assessed by blood test. If the AFP>=400ug/L, it would be recorded as the sign of recurrence or metastases, further examination such as abdominal contrast CT or chest X-ray should be performed.[every 1 month postoperation];Contrast CT scan and chest X-ray<br>Abdominal contrast CT scan was performed for surveillance of tumor recurrence.<br>Chest X-ray was performed for surveillance of lung metastases.[every 3 month postoperation];Abdominal ultrasound was performed for surveillance of tumor recurrence.[every 1 month postoperation]