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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 23, 2008 | ||||||||
| Last Updated Date | March 24, 2009 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
tumor recurrence rate in one or two years; Disease-free survival;Overall survival. [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00814242 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels | ||||||||
| Official Title ICMJE | A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels | ||||||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Hepatocellular Carcinoma | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | November 2011 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00814242 | ||||||||
| Responsible Party | Lehua Shi, Department of Comprehensive treatment I, Eastern Hepatobiliary Surgery Hospital | ||||||||
| Study ID Numbers ICMJE | EHBH-RCT-2008-009 | ||||||||
| Study Sponsor ICMJE | Eastern Hepatobiliary Surgery Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Eastern Hepatobiliary Surgery Hospital | ||||||||
| Verification Date | October 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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