HR Versus RFA for HCC in Patients With PHT

NCT ID: NCT02192671

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2022-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hepatic Resection

Intervention Type: PROCEDURE

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

Radiofrequency ablation

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

Group Type: ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type: PROCEDURE

Interventions

Hepatic Resection

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

Intervention Type: PROCEDURE

Radiofrequency Ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Hong Zhong

Affiliated Tumor Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian-Hong Zhong, MD

Role: CONTACT

zhongjianhong66@163.com

86-771-5330855

Facility Contacts

Jian-Hong Zhong, MD

Role: primary

zhongjianhong66@163.com

86-771-5330855

Other Identifiers

HRRFA-HCC/PHT

Identifier Type: REGISTRY

Identifier Source: secondary_id

HRRFA-HCC/PHT

Identifier Type: -

Identifier Source: org_study_id