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A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma at deep and complex sites (Adjacent to Major Blood Vessels)

A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma at deep and complex sites (Adjacent to Major Blood Vessels)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000180
Enrollment
Unknown
Registered
2008-11-17
Start date
2008-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC at deep and complex sites (adjacent to major blood vessels)

Interventions

PRFA group:CT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC
hepatectomy group:CT or Ultrasound-guided percutaneous radiofrequency

Sponsors

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with HCC in accordance with the clinical diagnostic criteria of HCC passed at the Chinese Eighth National Live Cancer Academic Conference. Patients with HCC should be confirmed by pathology. There is at least one measurable lesion; 2. 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 tumour 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 tumour thrombus of portal vein, hepatic vein, vena cava and bile duct; 3. 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; 4. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal; 5. Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.

Exclusion criteria

Exclusion criteria: 1. Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer; 2. Patients with other diseases which may affect the treatment mentioned here; 3. Patients with medical history of other malignant tumours; 4. Subjects participating in other clinical trials; 5. Women in pregnancy and breast-feeding; 6. Patients with tumour AJCC/UICC—TNM stage at IIIA period or below.

Design outcomes

Primary

MeasureTime frame
tumor recurrence rate, disease free survival rate,;

Secondary

MeasureTime frame
Overall survival rate in one, three or five years;disease free survival rate in one, three or five year;

Countries

China

Contacts

Public ContactLehua Shi
shilh@ehbh.cn+86 021 25070784

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026