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Hepatocellular CarcinomaNCT02046356

Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation

An observational study of Hepatocellular Carcinoma, run by Yunhua Tan at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim was to investigate the efficacy of radiofrequency ablation (RFA) with a multiple-electrode switching system (MESS) in the treatment of early hepatocellular carcinoma (HCC) and to evaluate the patterns and risk factors of intrahepatic recurrence of HCC after RFA. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
MESS-RFA
Type of treatment
Surgery or procedure
How many people
139 participants
Where
1 siteChina
Study dates
Jan 2014to Dec 2020
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In-patients from three affiliated hospital of the Third Military Medical University

Who may be able to join

  • 18-70 years old
  • The diameter of single tumor should be no more than 5cm, or multiple tumors(less than 3 loci) should be no more than 3cm. No large vascular invasion, no lymph nodes or extrahepatic metastases
  • The Classification of patients' liver function is Child - Pugh A or B
  • No serious coagulation dysfunction (prothrombin activity < 40% or platelet count < 30000 / mL).
  • No refractory ascites.
  • The patients can be treated with RFA in clinical
Show all 9Show fewer
  • Primary treatment by RFA should ablate the tumor(s) completely
  • The patients are aware of their condition, the treatment of the HCC, and the risks associated with radiofrequency ablation therapy.
  • The patients participant voluntarily and they will sign the informed consent before the radiofrequency ablation therapy.

Who cannot join

  • The patients are from abroad, Hong Kong, Macao, Taiwan and other regions, who are impossible to be follow-up
  • The patients who refuse to sign the informed consent
  • Tumor emboli existed in main portal vein, ductus hepatics communis and(or) its primary branch, main hepatic vein and(or) inferior vena cava before operation
  • Extrahepatic metastasis, lymph node metastasis
  • The patients whom accept systemic chemotherapy, preoperative interventional therapy, and(or) other auxiliary treatment
  • The patients with diabetes mellitus, heart disease and(or) other diseases can't tolerate radiofrequency ablation, or influence postoperative follow-up
Show all 9Show fewer
  • The existence of other type of malignant tumor before or accompanied by HCC
  • Primary treatment by RFA do not ablate the tumor(s) completely
  • Non-primary liver tumor, such as the liver metastatic carcinoma, cholangiocarcinoma, etc

Trial locations and contacts

1 site in 1 country.

China1 site

  • Southwest hospital

    Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

Official title: Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation: a Multi-center Prospective Case-control Study

The aim was to investigate the efficacy of radiofrequency ablation (RFA) with a multiple-electrode switching system (MESS) in the treatment of early hepatocellular carcinoma (HCC) and to evaluate the patterns and risk factors of intrahepatic recurrence of HCC after RFA.

Read the detailed description

Percutaneous RFA has become a particularly promising treatment for patients with early HCC. For HCC with a diameter less than 3cm, RFA is becoming an effective topical method for the goal of a complete cure. Although RFA is successful for small HCCs, for HCCs with a diameter larger than 3 to 5 cm, the complete ablation rate is reported to range from 61.3% to 82.5%. These results may be obsolete due to the further development of RFA techniques and instruments. For example, the use of clustered electrodes and an improved motor can provide a higher power, and the multiple-electrode switching system RFA (MESS-RFA) uses various methods to create a sufficient ablation zone, the investigators need to further update the management strategy of the RFA treatment of early HCC.

However, HCC recurrence after RFA is still a significant problem . the investigators divide the intrahepatic recurrence after RFA into local tumor progression (LTP) and intrahepatic distant recurrence (IDR); each type of recurrence has a different pathogenic mechanism and is thought to occur relatively independently . Understanding the pattern and risk factors of recurrence is very important for the development of RFA and its clinical application.

The objective of our multicenter prospective study was to evaluate the efficacy of MESS-RFA as a primary method for treating early HCC, to assess the pattern of intrahepatic recurrence according to the types of recurrence, and to determine the risk factors associated with tumor recurrence and survival.

Being tested
MESS-RFA
Keywords
hepatocellular carcinoma, radiofrequency ablation, Milan Criteria, recurrence, risk factor
Medical subject headings
Carcinoma, Hepatocellular, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MESS-RFAProcedure or surgery

Study groups in NCT02046356
Study groupRoleWhat they receive
Early-Stage HCCEarly-Stage hepatocellular carcinoma From January 2014 to January 2015, a total of 139 patients with early HCC from the First Affiliated Hospital, the Second Affiliated Hospital and the Third Affiliated Hospital of the Third Military Medical University were prospectively recruited according after MESS-RFA
Receives: Procedure: MESS-RFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success

    Complete ablation rate

    Measured: up to 5 years

Secondary outcomes (4)

  1. LTP

    local tumor progression

    Measured: up to 5 years

  2. IDR

    intrahepatic distant recurrence

    Measured: up to 5 years

  3. Overall survival

    Overall survival rates

    Measured: up to 5 years

  4. IDR-free survival

    IDR-free survival rates

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2015
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
139 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02046356
Sponsor's protocol ID
SWH-66
Other IDs
SouthwestH
Status last verified
Oct 2020
First submitted
23 Jan 2014
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Shiina S, Tateishi R, Arano T, Uchino K, Enooku K, Nakagawa H, Asaoka Y, Sato T, Masuzaki R, Kondo Y, Goto T, Yoshida H, Omata M, Koike K. Radiofrequency ablation for hepatocellular carcinoma: 10-year outcome and prognostic factors. Am J Gastroenterol. 2012 Apr;107(4):569-77; quiz 578. doi: 10.1038/ajg.2011.425. Epub 2011 Dec 13.

    PubMed 22158026

  • Arii S, Yamaoka Y, Futagawa S, Inoue K, Kobayashi K, Kojiro M, Makuuchi M, Nakamura Y, Okita K, Yamada R. Results of surgical and nonsurgical treatment for small-sized hepatocellular carcinomas: a retrospective and nationwide survey in Japan. The Liver Cancer Study Group of Japan. Hepatology. 2000 Dec;32(6):1224-9. doi: 10.1053/jhep.2000.20456.

    PubMed 11093728

  • Hasegawa K, Makuuchi M, Takayama T, Kokudo N, Arii S, Okazaki M, Okita K, Omata M, Kudo M, Kojiro M, Nakanuma Y, Takayasu K, Monden M, Matsuyama Y, Ikai I. Surgical resection vs. percutaneous ablation for hepatocellular carcinoma: a preliminary report of the Japanese nationwide survey. J Hepatol. 2008 Oct;49(4):589-94. doi: 10.1016/j.jhep.2008.05.018. Epub 2008 Jun 12.

    PubMed 18620773

  • Ng KK, Poon RT, Lo CM, Yuen J, Tso WK, Fan ST. Analysis of recurrence pattern and its influence on survival outcome after radiofrequency ablation of hepatocellular carcinoma. J Gastrointest Surg. 2008 Jan;12(1):183-91. doi: 10.1007/s11605-007-0276-y. Epub 2007 Sep 15.

    PubMed 17874276

  • Lam VW, Ng KK, Chok KS, Cheung TT, Yuen J, Tung H, Tso WK, Fan ST, Poon RT. Risk factors and prognostic factors of local recurrence after radiofrequency ablation of hepatocellular carcinoma. J Am Coll Surg. 2008 Jul;207(1):20-9. doi: 10.1016/j.jamcollsurg.2008.01.020. Epub 2008 Apr 24.

    PubMed 18589357

  • Kudo M. Radiofrequency ablation for hepatocellular carcinoma: updated review in 2010. Oncology. 2010 Jul;78 Suppl 1:113-24. doi: 10.1159/000315239. Epub 2010 Jul 8.

    PubMed 20616593

  • Lee HY, Rhim H, Lee MW, Kim YS, Choi D, Park MJ, Kim YK, Kim SH, Lim HK. Early diffuse recurrence of hepatocellular carcinoma after percutaneous radiofrequency ablation: analysis of risk factors. Eur Radiol. 2013 Jan;23(1):190-7. doi: 10.1007/s00330-012-2561-8. Epub 2012 Oct 20.

    PubMed 23085860

  • Tan Y, Wang X, Ma K, Zhang L, Li J, Chen P, Zhang B. Risk factors for the recurrence of early hepatocellular carcinoma treated by percutaneous radiofrequency ablation with a multiple-electrode switching system: a multicenter prospective study. Int J Hyperthermia. 2022;39(1):190-199. doi: 10.1080/02656736.2021.2024279.

    PubMed 35042449

  • Tan Y, Jiang J, Wang Q, Guo S, Ma K, Bie P. Radiofrequency ablation using a multiple-electrode switching system for hepatocellular carcinoma within the Milan criteria: long-term results. Int J Hyperthermia. 2018 May;34(3):298-305. doi: 10.1080/02656736.2017.1330495. Epub 2017 May 29.

    PubMed 28554226

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Yunhua Tan at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046356, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.

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