NCT02192671

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

7.3 years

First QC Date

July 15, 2014

Last Update Submit

January 14, 2022

Conditions

Carcinoma, HepatocellularLiver NeoplasmsNeoplasms, Glandular and Epithelial

Keywords

hepatocellular carcinomaradiofrequency ablationhepatic resectionportal hypertensionMilan criteriarandomized critical trial

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    3 years

  • Hospital mortality

    90 day

Secondary Outcomes (1)

  • Recurrence rate

    3 years

Study Arms (2)

Hepatic resection

EXPERIMENTAL

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

Radiofrequency ablation

ACTIVE COMPARATOR

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

Procedure: Radiofrequency Ablation

Interventions

Hepatic ResectionPROCEDURE

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

Hepatic resection
Radiofrequency AblationPROCEDURE
Radiofrequency ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsNeoplasms, Glandular and EpithelialHypertension, Portal

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Jian-Hong Zhong, MD

CONTACT

86-771-5330855zhongjianhong66@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Tumor Hospital

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

May 1, 2015

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

CN(1)