HR Versus RFA for HCC in Patients With PHT

Carcinoma, Hepatocellular Clinical Trial

— HR-HCC/PHT  

Official title:

Hepatic Resection Versus Radiofrequency Ablation for Patients With Hepatocellular Carcinoma and Portal Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02192671
• Other study ID #: HRRFA-HCC/PHT
• Secondary ID: HRRFA-HCC/PHT
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Guangxi Medical University
• Contact: Jian-Hong Zhong, MD
• Phone: 86-771-5330855
• Email: zhongjianhong66[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 a-fetoprotein higher than 400 ng/mL. If diagnosis based on imaging anda-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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Neoplasms
• Neoplasms, Glandular and Epithelial

Intervention

Procedure:
• Hepatic Resection
Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.
• Radiofrequency Ablation

Locations

Country	Name	City	State
China	Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years
Primary	Hospital mortality		90 day
Secondary	Recurrence rate		3 years