A prospective randomized trial comparing surgery therapy versus radiotherapy combined with transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with portal vein invasion

Compare the effect of surgery therapy versus radiotherapy Combined with transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with portal vein invasion

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000751875

Enrollment

360

Registered

2012-07-13

Start date

2008-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To compare the results of surgical resection with three-dimensional conformal radiotherapy (3D-CRT) in the treatment of resectable hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Interventions

Liver resection was carried out by a clamp crushing method with Pringle maneuver. The clamp crushing method is a fracture or crushing technique during the parechymatous transection of the liver tissue by using a clamp.Pringle maneuver is a method of inflow hepatic vascular occlusion in liver resection.Thrombectomy was performed if necessary depending on the location and extent of the portal vein tumor thrombus (PVTT).The surgery lasts 2-3 hours which was decided by the time of liver resection.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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

Outcome results