Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels
|Hepatocellular Carcinoma||Procedure: surgical resection Procedure: percutaneous radiationfrequency ablation||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels|
- tumor recurrence rate in one or two years; Disease-free survival;Overall survival. [ Time Frame: 1,2,or 3 years ]
- Overall survival rate in one, two，three or five years; Disease-free survival in one, two，three or five years; hepatic function of patients after surgery, the incidence rate of complications and the decline level of serum AFP concentration. [ Time Frame: one, two，three or five years ]
|Study Start Date:||December 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: hepatectomy
Patients with HCC adjacent to major blood vessels recieved radical resection.
Procedure: surgical resection
radical resection performed in patinets with HCC.
Other Name: hepatectomy group
Experimental: percutaneous radiationfrequency ablation
CT or Ultrasound-guided percutaneous radiofrequency ablation
Procedure: percutaneous radiationfrequency ablation
CT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC
Other Name: PRFA Goup
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying. In recent years, lots of clinical practice and a small amount of evidence-based medicine show that: ①.Surgical treatment is still the preferred choice of the treatment of HCC. ②. The standardization of comprehensive treatment should be put in top priority in current treatment of HCC. Rational treatment methods should be adopted in accordance with specific conditions of patients. The best and latest treatment methods should also be provided to improve the efficacy to the largest extent for the benefit of the majority of patients with HCC.
Today, tumor remaining in a patient after therapy with curative intent(eg. surgical resection for cure ) is categorized by a system known as R classification. That is shown: RX: presence of residual tumor can not be assessed; R0: no residual tumor; R1: microscopic residual tumor; R2: macroscopic residual tumor; The residue with the application of R classification not only refers to both residual tumor at the margin of surgical excision but also residue in distant metastasis. The higher R classification is, the worse the prognosis becomes.
Most studies have been leaded a good result By now that percutaneous radiationfrequency ablation(PRFA) is efficacious and safe for patients with HCC. In patients with HCC smaller than 3cm, PRFA may be comparable to suegical resection in long-term outcome.
At present, radical resection (for the final R0 or R1) performed in HCC at most deep and complex sites (including caudate lobe HCC, 8th segment hepatoma adjacent to the trunk of inferior vena cava, hepatic vein and portal vein, etc) often lead to serious damage to major blood vessels (i.e., hepatic vein, short hepatic vein, portal vein and inferior vena cava) and hemorrhage during surgery. Therefore, when the surgeon performs surgery near major sites, he should excise as few normal liver tissues as possible to avoid above-mentioned hazard. However, the resection margin may not be complete and thus affect radical effect. In addition, as the tumor is rather deep located, lots of normal liver tissues on the surface of the tumor are excised with massive bleeding and serious damage. In view of this situation, the surgeon will adopt some alternatives (PRFA is rather common) to achieve the efficacy similar to liver excision and greatly reduce the risk of vascular injury and some complications like hepatic insufficiency. However, there are no studies on the efficacy comparison between this treatment method and the efficacy of liver excision, time to recurrence (TTR)stage, disease-free survival and overall survival condition.
This study will compare and analyze the difference between hepatectomy at deep and complex sites of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence of complications so as to establish treatment standards of HCC at these sites.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814242
|Eastern Hepatobiliary Surgery Hospital|
|Shanghai, Shanghai, China, 200438|
|Study Chair:||Feng Shen, M.D.||Eastern Hepatobiliary Surgery Hospital, Second Military Medical University|