|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eastern Hepatobiliary Surgery Hospital |
|---|---|
| Information provided by: | Eastern Hepatobiliary Surgery Hospital |
| ClinicalTrials.gov Identifier: | NCT00814242 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Procedure: surgical resection Procedure: percutaneous radiationfrequency ablation |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lehua Shi, M.D. | 0086-21-25070784 | shilh@ehbh.cn |
| Contact: Yong Xia, M.D. | 0086-21-25074943 | xiay99@hotmail.com; |
| China, Shanghai | |
| Eastern Hepatobiliary Surgery Hospital | Recruiting |
| Shanghai, Shanghai, China, 200438 | |
| Contact: Lehua Shi, M.D. 0086-021-25070784 Shilh@ehbh.cn | |
| Contact: Yong Xia, M.D. 0086-021-25077943 xiay99@hotmail.com | |
| Principal Investigator: Lehua Shi, M.D. | |
| Study Chair: | Feng Shen, M.D. | Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
More Information
| Responsible Party: | Lehua Shi, Department of Comprehensive treatment I, Eastern Hepatobiliary Surgery Hospital |
| ClinicalTrials.gov Identifier: | NCT00814242 History of Changes |
| Other Study ID Numbers: | EHBH-RCT-2008-009 |
| Study First Received: | December 23, 2008 |
| Last Updated: | March 24, 2009 |
| Health Authority: | China: Ministry of Health |
|
Hepatocellular Carcinoma Adjacent to Major Blood Vessels Surgical resection Ppercutaneous radiationfrequency ablation |
Time to recurrence Disease-free survival Overall survival |
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |