Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00814242
First received: December 23, 2008
Last updated: March 24, 2009
Last verified: October 2008
  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 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Identify patients with HCC in accordance with the clinical diagnostic criteria of HCC passed at the Chines Eighth National Live Cancer Academic Conference. Patients with HCC shall be diagnosed with pathology. There is at least one measurable lesion.
  • Hepatoma involved in this research at complex site is located at the eighth segment of liver, the substantial depth of liver below hepatic integument adjacent to the trunk of inferior vena cava, hepatic vein and portal vein. The tumor is located at hepatic caudate lobe. The maximal diameter < or=3m, AJCC/UICC—TNM stage is stage II and above. Lesions are determined by three senior hepatobiliary experts independently, therefore radical resection is possible. There is no possibility of extra-hepatic metastasis and tumor thrombus of portal vein, hepatic vein, vena cava and bile duct.
  • Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. It's appropriate to perform liver resection and minimally invasive treatment.
  • No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  • Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.

Exclusion Criteria:

  • Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
  • Patients with other diseases which may affect the treatment mentioned here.
  • Patients with medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • Women in pregnancy and breast-feeding.
  • Patients with tumor AJCC/UICC—TNM stage at IIIA period or below.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814242

Contacts
Contact: Lehua Shi, M.D. 0086-21-25070784 shilh@ehbh.cn
Contact: Yong Xia, M.D. 0086-21-25074943 xiay99@hotmail.com;

Locations
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.         
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Feng Shen, M.D. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

No publications provided

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

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Hepatocellular Carcinoma
Adjacent to Major Blood Vessels
Surgical resection
Ppercutaneous radiationfrequency ablation
Time to recurrence
Disease-free survival
Overall survival

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014