NCT02724475

Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research.

Conditions

• Hepatocellular Carcinoma
• Laser Ablation
• Portal Vein Tumor Thrombus

Interventions

Type	Name	Description
PROCEDURE	LA	Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated
PROCEDURE	3D-CRT	γ-knife treatment with radiation dose of 48-63 Gy/6-9 times

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2015-12-01
• First posted: 2016-03-31
• Last updated: 2016-03-31

Locations

1 site across 1 country: China