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

NCT00814242 | Completed Phase 2 DMC

• 1 other identifier: EHBH-RCT-2008-009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Adjacent to Major Blood Vessels; Surgical resection; Ppercutaneous radiationfrequency ablation; Time to recurrence; Disease-free survival; Overall survival

Outcome Measures

Primary Outcomes (1)

• tumor recurrence rate in one or two years; Disease-free survival;Overall survival.

  1,2,or 3 years

Secondary Outcomes (1)

• 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.

  one, two，three or five years

Study Arms (2)

hepatectomy

ACTIVE COMPARATOR

Patients with HCC adjacent to major blood vessels recieved radical resection.

Procedure: surgical resection

percutaneous radiationfrequency ablation

EXPERIMENTAL

CT or Ultrasound-guided percutaneous radiofrequency ablation

Procedure: percutaneous radiationfrequency ablation

Interventions

surgical resection PROCEDURE

radical resection performed in patinets with HCC.

Also known as: hepatectomy group

hepatectomy

percutaneous radiationfrequency ablation PROCEDURE

CT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC

Also known as: PRFA Goup

percutaneous radiationfrequency ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Feng Shen, M.D.

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2011
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)