Status:
UNKNOWN
HR Versus RFA for HCC in Patients With PHT
Lead Sponsor:
Guangxi Medical University
Conditions:
Carcinoma, Hepatocellular
Liver Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of the investigators' study is to prospectively compare the safety and efficacy of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients with portal hyperte...
Detailed Description
Cirrhosis is common among patients with hepatocellular carcinoma (HCC); in China, for example, it occurs in approximately 80% of HCC patients. Another common comorbidity of HCC is clinically significa...
Eligibility Criteria
Inclusion
- Age 18-75 years
- In the HR group, clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients; in the RFA group, HCC diagnosis was confirmed by two types of clinical imaging (ultrasonography, computed tomography, or magnetic resonance imaging), togetherwith a serum level of α-fetoprotein higher than 400 ng/mL. If diagnosis based on imaging andα-fetoprotein level was uncertain, needle biopsy was performed.
- Tumor stage fitted into Milan Criteria
- Patients with clinically relevant portal hypertension, which is defined as the presence of esophageal varices and/or a platelet count of less than 100 000 per μL in association with splenomegaly.
- Patients have Child-Pugh A or B liver function
- No previous neoadjuvant treatment
- No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- No malignancy other than HCC for 5 years prior to the initial HCC treatment
Exclusion
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
- Known Central Nervous System tumors including metastatic brain disease
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients.
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02192671
Start Date
May 1 2015
End Date
December 1 2022
Last Update
January 18 2022
Active Locations (1)
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1
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
Nanning, Guangxi, China, 530021