HR-HCC/PHT: HR Versus RFA for HCC in Patients With PHT

Sponsor

Guangxi Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02192671

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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 hypertension.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial	Procedure: Hepatic Resection Procedure: Radiofrequency Ablation	Phase 3

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepatic resection Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.	Procedure: Hepatic Resection Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.
Active Comparator: Radiofrequency ablation RFA is performed in less than one week after clinical diagnosis.	Procedure: Radiofrequency Ablation

Arm

Intervention/Treatment

Experimental: Hepatic resection

Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.

Procedure: Hepatic Resection

Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.

Active Comparator: Radiofrequency ablation

RFA is performed in less than one week after clinical diagnosis.

Procedure: Radiofrequency Ablation

Outcome Measures

Primary Outcome Measures

Overall survival [3 years]
Hospital mortality [90 day]

Secondary Outcome Measures

Recurrence rate [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.