HR Versus RFA for HCC in Patients With PHT (HR-HCC/PHT)

  • STATUS
    Recruiting
  • days left to enroll
    17
  • participants needed
    120
  • sponsor
    Guangxi Medical University
Updated on 22 March 2022
ct scan
platelet count
cancer
carcinoma
metastasis
adjuvant therapy
radiofrequency ablation
hepatocellular carcinoma

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 hypertension.

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 significant portal hypertension (PHT), which occurs in 25-55% of patients with both HCC and cirrhosis. PHT correlates with the severity of cirrhosis, and it can complicate HCC treatment by increasing the risk of perioperative hemorrhage and liver failure.

Hepatic resection (HR) is a widely used radical therapy for HCC. Although HR is often suitable for HCC patients with cirrhosis, it is widely regarded as unsuitable for HCC patients with PHT because of the potential for postoperative hepatic decompensation. In fact, the absence of PHT is the best predictor of excellent HR outcomes. Guidelines of the American and European Associations for the Study of Liver Disease do not recommend HR as an option for HCC patients with PHT. Several studies, however, have reported that HCC patients with and without clinically significant PHT showed similar short- and long-term outcomes after HR. This controversy is important to resolve because more than 25% of cirrhotic patients with HCC also present with PHT.

Actually, official guidelines recommend liver transplatation for patients with HCC and PHT. However, implementation of liver transplantation is restricted by the lack of liver donation and the high cost of the procedure in many countries, especially China. However, as a minimally invasive therapy, radiofrequency ablation (RFA) is a popular treatment modality for patients with HCC within Milan Criteria. Moreover, randomized controlled trials have validated and proposed its clinical usage.

So here, we plan to address the safety and efficacy of HR comparing with RFA for HCC patients with PHT using a population from Guangxi province of China, where the population shows the highest HCC incidence in the world.

Details
Condition Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasms, Glandular and Epithelial
Treatment Radiofrequency ablation, Hepatic resection
Clinical Study IdentifierNCT02192671
SponsorGuangxi Medical University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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