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

NCT02243384 | Completed DMC

• 1 other identifier: chenjian-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Early Hepatocellular Carcinoma; Laparoscopic Hepatectomy; Radiofrequency Ablation; Micrometastases

Outcome Measures

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.

  5 years

Secondary Outcomes (1)

• postoperative complications

  Duration hospitalization(an expected average of 7 days)

Study Arms (2)

Laparoscopic Hepatectomy

EXPERIMENTAL

Laparoscopic Hepatectomy

Procedure: Laparoscopic Hepatectomy

Radiofrequency Ablation

ACTIVE COMPARATOR

Radiofrequency Ablation

Procedure: Radiofrequency Ablation

Interventions

Laparoscopic Hepatectomy PROCEDURE

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

Laparoscopic Hepatectomy

Radiofrequency Ablation PROCEDURE

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

Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ChenJian: lead

Study Sites (1)

JianChen

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (24)

• 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.

  PMID: 19383082 RESULT

• 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.

  PMID: 21374666 RESULT

• 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.

  PMID: 20590903 RESULT

• 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.

  PMID: 18283144 RESULT

• Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.

  PMID: 1833688 RESULT

• 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.

  PMID: 24368662 RESULT

• 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.

  PMID: 21259071 RESULT

• 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.

  PMID: 21079109 RESULT

• 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.

  PMID: 11088070 RESULT

• 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.

  PMID: 19652902 RESULT

• 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.

  PMID: 22968066 RESULT

• 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.

  PMID: 20610244 RESULT

• 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.

  PMID: 21377584 RESULT

• 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.

  PMID: 19106671 RESULT

• 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.

  PMID: 16041205 RESULT

• 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.

  PMID: 22634125 RESULT

• 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.

  PMID: 19916210 RESULT

• 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.

  PMID: 23099728 RESULT

• 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.

  PMID: 19300227 RESULT

• 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.

  PMID: 21179308 RESULT

• 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.

  PMID: 17197963 RESULT

• 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.

  PMID: 21107101 RESULT

• 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.

  PMID: 21107100 RESULT

• Song J, Cao L, Ma K, Li J, Wang X, Chen J, Zheng S. Laparoscopic liver resection versus radiofrequency ablation for small hepatocellular carcinoma: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae099. doi: 10.1093/bjs/znae099.

  PMID: 38650579 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Micrometastasis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jian Chen

  Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and researchers do not understand the test grouping, but the research designer arranges and controls all trials.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

CN (1)