Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will compare and analyze the difference between hepatectomy at deep and complex
      sites(adjacent to major blood vessels) 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.
    

Detailed description: 
      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.
    

Intervention name(s): surgical resection; percutaneous radiationfrequency ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): radical resection performed in patinets with HCC.; CT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC
Other intervention name(s): hepatectomy group; PRFA Goup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Adjacent to Major Blood Vessels; Surgical resection; Ppercutaneous radiationfrequency ablation; Time to recurrence; Disease-free survival; Overall survival