NCT01713244

Brief Summary

RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.

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
150

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable hepatocellular-carcinoma

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

Study Start

First participant enrolled

October 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

4 years

First QC Date

October 21, 2012

Last Update Submit

November 19, 2015

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaRadiofrequency AblationHepatectomyRecurrence

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    2 years

Secondary Outcomes (1)

  • Overall Survival

    2 years

Other Outcomes (1)

  • Number of participants with adverse events

    2 years

Study Arms (2)

Hepatectomy

ACTIVE COMPARATOR

Using Hepatectomy for the treatment of advanced HCC

Procedure: Hepatectomy

RFA assisted Hepatectomy

EXPERIMENTAL

Ablating the liver tissue around the tumor before hepatectomy.

Procedure: RFA assisted Hepatectomy

Interventions

RFA assisted HepatectomyPROCEDURE

Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.

RFA assisted Hepatectomy
HepatectomyPROCEDURE

Treat the advanced HCC with the hepatectomy only.

Hepatectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of HCC confirmed at our hospital.
  • Intrahepatic tumor count no higher than 3 and a minimum tumor diameter \> 3 cm, but no more than 8cm.
  • Liver function of Child-Pugh Class A or B.
  • Tumors lacked intrahepatic and extrahepatic metastasis.
  • Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
  • Indocyanine green retention at 15 minutes (ICG-15) of \<10%.
  • No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds.
  • No other anti-tumor therapy received before the treatment. -

You may not qualify if:

  • Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
  • Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kuansheng Ma, Ph.D

    Institute of hepatobiliary surgery,Southwest Hospital

    STUDY DIRECTOR

Central Study Contacts

Kai Feng, M.D

CONTACT

+86-23-13228683383fengkai7688@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Hepatobiliary Surgery

Study Record Dates

First Submitted

October 21, 2012

First Posted

October 24, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CN(1)