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CompletedNCT02243384Updated Jun 2, 2022

Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma

An interventional study of Laparoscopic Hepatectomy and Radiofrequency Ablation in Hepatocellular Carcinoma, sponsored by ChenJian. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by ChenJian · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this research is to compare short-term and long-term efficacy of laparoscopic hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma, and provide the evidence for the choice of surgical method from the pathology and cytology.

Read the detailed description

Background:The aim of this study was to compare the efficacy of laparoscopic hepatectomy(LH) with radiofrequency ablation (RFA) in the treatment of early hepatocellular carcinoma (HCC).

Methods:A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period.

Results:

operation time, intraoperative blood loss, rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, number of micrometastases ,long-term curative effect and survival time were collected and analysed.

groups t-test ,univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ,Kaplan-Meier survival analysis,Log-rank survival curves were used.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Early Hepatocellular Carcinoma
  • Laparoscopic Hepatectomy
  • Radiofrequency Ablation
  • Micrometastases
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 150 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with ChenJian as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any gender,18 to 70 years old;
  • Preoperative diagnosis of primary liver clear;
  • No active hepatitis and decompensated cirrhosis;
  • Maximum diameter ≤3cm single nodules or three nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
  • No tumor rupture or bleeding;
  • Child-Pugh class A or B grade,ICG-R15 \<14%;
  • No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time \< 5 seconds;
  • Not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
  • Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
  • Voluntarily participate in the study,informed consent.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years or > 70,pregnant and lactating women;
  • Primary liver cancer diagnosis is not clear
  • Liver function assessment:Child-PughC level,liver function reserve situation :ICGR-15> 14%
  • Tumor rupture has occurred,or has the line before surgery,radiofrequency ablation (RFA),TACE or chemotherapy cancer treatment;
  • Tips liver imaging with multiple ( > 3 ) lesion,or tumor diameter> 3 cm, clear portal vein,hepatic vein,inferior vena cava tumor thrombus trunk;
  • Preoperative liver metastasis;
  • Preoperative evaluation of cardiopulmonary dysfunction patients who can not tolerate surgery;
  • Intraoperative exploration has occurred disseminated tumor and / or lymph node metastasis;
  • Exploratory surgery found that non-hepatic primary tumors,such as colorectal metastases,hilar cell carcinoma;
  • Severe upper abdominal adhesions;
  • Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
  • Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Laparoscopic Hepatectomy

    Laparoscopic Hepatectomy

    Procedure: Laparoscopic Hepatectomy

  • Active comparator
    Radiofrequency Ablation

    Radiofrequency Ablation

    Procedure: Radiofrequency Ablation

Interventions

  • ProcedureLaparoscopic Hepatectomy

    A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period

  • ProcedureRadiofrequency Ablation

    A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period

06

What researchers measure

Primary outcomes

  1. Survival rate

    follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 2-year and 3-year survival, disease-free survival, recurrence rate.

    Time frame: 5 years

Secondary outcomes

  1. postoperative complications

    hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.

    Time frame: Duration hospitalization(an expected average of 7 days)

07

Study locations

1 site
  • JianChen
    Chongqing, Chongqing 400038, China
08

References and documents

Publications

  • Amarapurkar D, Han KH, Chan HL, Ueno Y; Asia-Pacific Working Party on Prevention of Hepatocellular Carcinoma. Application of surveillance programs for hepatocellular carcinoma in the Asia-Pacific Region. J Gastroenterol Hepatol. 2009 Jun;24(6):955-61. doi: 10.1111/j.1440-1746.2009.05805.x. Epub 2009 Mar 11. PubMed 19383082 ↗
  • Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available. PubMed 21374666 ↗
  • Jarnagin W, Chapman WC, Curley S, D'Angelica M, Rosen C, Dixon E, Nagorney D; American Hepato-Pancreato-Biliary Association; Society of Surgical Oncology; Society for Surgery of the Alimentary Tract. Surgical treatment of hepatocellular carcinoma: expert consensus statement. HPB (Oxford). 2010 Jun;12(5):302-10. doi: 10.1111/j.1477-2574.2010.00182.x. PubMed 20590903 ↗
  • Zimmerman MA, Ghobrial RM, Tong MJ, Hiatt JR, Cameron AM, Hong J, Busuttil RW. Recurrence of hepatocellular carcinoma following liver transplantation: a review of preoperative and postoperative prognostic indicators. Arch Surg. 2008 Feb;143(2):182-8; discussion 188. doi: 10.1001/archsurg.2007.39. PubMed 18283144 ↗
  • Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8. PubMed 1833688 ↗
  • Kobayashi T. Long-term Survival Analysis of Pure Laparoscopic Versus Open Hepatectomy for Hepatocellular Carcinoma in Patients With Cirrhosis: A Single-center Experience. Ann Surg. 2015 Jul;262(1):e20. doi: 10.1097/SLA.0000000000000443. No abstract available. PubMed 24368662 ↗
  • Zhou YM, Shao WY, Zhao YF, Xu DH, Li B. Meta-analysis of laparoscopic versus open resection for hepatocellular carcinoma. Dig Dis Sci. 2011 Jul;56(7):1937-43. doi: 10.1007/s10620-011-1572-7. Epub 2011 Jan 23. PubMed 21259071 ↗
  • Nguyen KT, Marsh JW, Tsung A, Steel JJ, Gamblin TC, Geller DA. Comparative benefits of laparoscopic vs open hepatic resection: a critical appraisal. Arch Surg. 2011 Mar;146(3):348-56. doi: 10.1001/archsurg.2010.248. Epub 2010 Nov 15. PubMed 21079109 ↗
  • Cherqui D, Husson E, Hammoud R, Malassagne B, Stephan F, Bensaid S, Rotman N, Fagniez PL. Laparoscopic liver resections: a feasibility study in 30 patients. Ann Surg. 2000 Dec;232(6):753-62. doi: 10.1097/00000658-200012000-00004. PubMed 11088070 ↗
  • Otsuka Y, Tsuchiya M, Maeda T, Katagiri T, Isii J, Tamura A, Yamazaki K, Kubota Y, Suzuki T, Suzuki T, Kagami S, Kaneko H. Laparoscopic hepatectomy for liver tumors: proposals for standardization. J Hepatobiliary Pancreat Surg. 2009;16(6):720-5. doi: 10.1007/s00534-009-0139-x. Epub 2009 Aug 4. PubMed 19652902 ↗
  • Ishizawa T, Gumbs AA, Kokudo N, Gayet B. Laparoscopic segmentectomy of the liver: from segment I to VIII. Ann Surg. 2012 Dec;256(6):959-64. doi: 10.1097/SLA.0b013e31825ffed3. PubMed 22968066 ↗
  • Dagher I, Belli G, Fantini C, Laurent A, Tayar C, Lainas P, Tranchart H, Franco D, Cherqui D. Laparoscopic hepatectomy for hepatocellular carcinoma: a European experience. J Am Coll Surg. 2010 Jul;211(1):16-23. doi: 10.1016/j.jamcollsurg.2010.03.012. Epub 2010 May 26. PubMed 20610244 ↗
  • Livraghi T. Radiofrequency ablation of hepatocellular carcinoma. Surg Oncol Clin N Am. 2011 Apr;20(2):281-99, viii. doi: 10.1016/j.soc.2010.11.010. PubMed 21377584 ↗
  • Lau WY, Lai EC. The current role of radiofrequency ablation in the management of hepatocellular carcinoma: a systematic review. Ann Surg. 2009 Jan;249(1):20-5. doi: 10.1097/SLA.0b013e31818eec29. PubMed 19106671 ↗
  • Mulier S, Ni Y, Jamart J, Ruers T, Marchal G, Michel L. Local recurrence after hepatic radiofrequency coagulation: multivariate meta-analysis and review of contributing factors. Ann Surg. 2005 Aug;242(2):158-71. doi: 10.1097/01.sla.0000171032.99149.fe. PubMed 16041205 ↗
  • Feng K, Yan J, Li X, Xia F, Ma K, Wang S, Bie P, Dong J. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma. J Hepatol. 2012 Oct;57(4):794-802. doi: 10.1016/j.jhep.2012.05.007. Epub 2012 May 23. PubMed 22634125 ↗
  • Buell JF, Cherqui D, Geller DA, O'Rourke N, Iannitti D, Dagher I, Koffron AJ, Thomas M, Gayet B, Han HS, Wakabayashi G, Belli G, Kaneko H, Ker CG, Scatton O, Laurent A, Abdalla EK, Chaudhury P, Dutson E, Gamblin C, D'Angelica M, Nagorney D, Testa G, Labow D, Manas D, Poon RT, Nelson H, Martin R, Clary B, Pinson WC, Martinie J, Vauthey JN, Goldstein R, Roayaie S, Barlet D, Espat J, Abecassis M, Rees M, Fong Y, McMasters KM, Broelsch C, Busuttil R, Belghiti J, Strasberg S, Chari RS; World Consensus Conference on Laparoscopic Surgery. The international position on laparoscopic liver surgery: The Louisville Statement, 2008. Ann Surg. 2009 Nov;250(5):825-30. doi: 10.1097/sla.0b013e3181b3b2d8. PubMed 19916210 ↗
  • Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26. PubMed 23099728 ↗
  • Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f. PubMed 19300227 ↗
  • Minami Y, Kudo M. Radiofrequency ablation of hepatocellular carcinoma: Current status. World J Radiol. 2010 Nov 28;2(11):417-24. doi: 10.4329/wjr.v2.i11.417. PubMed 21179308 ↗
  • Shi M, Guo RP, Lin XJ, Zhang YQ, Chen MS, Zhang CQ, Lau WY, Li JQ. Partial hepatectomy with wide versus narrow resection margin for solitary hepatocellular carcinoma: a prospective randomized trial. Ann Surg. 2007 Jan;245(1):36-43. doi: 10.1097/01.sla.0000231758.07868.71. PubMed 17197963 ↗
  • Curley SA. Radiofrequency ablation leads to excellent local tumor control and durable longterm survival in specific subsets of early stage HCC patients confirming to the Milan criteria. Ann Surg. 2010 Dec;252(6):913-4. doi: 10.1097/SLA.0b013e3182034862. No abstract available. PubMed 21107101 ↗
  • Huang J, Yan L, Cheng Z, Wu H, Du L, Wang J, Xu Y, Zeng Y. A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria. Ann Surg. 2010 Dec;252(6):903-12. doi: 10.1097/SLA.0b013e3181efc656. PubMed 21107100 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02243384
Lead sponsor
ChenJian
Responsible party
ChenJian (Associate Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department, Southwest Hospital, China) — Sponsor-investigator
First posted
Sep 17, 2014
Start date
Sep 1, 2014
Primary completion
Jan 1, 2021
Completion
Oct 1, 2021
Last update
Jun 2, 2022

Study contacts

Jian Chen
study chair · Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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