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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243384
• Other study ID #: chenjian-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: October 1, 2021

Study information

• Verified date: May 2022
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Laparoscopic 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
• Radiofrequency 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

Locations

Country	Name	City	State
China	JianChen	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
ChenJian

Country where clinical trial is conducted

China, 

References & Publications (23)

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 — View Citation

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. — View Citation

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 — View Citation

Cherqui D, Husson E, Hammoud R, Malassagne B, Stéphan F, Bensaid S, Rotman N, Fagniez PL. Laparoscopic liver resections: a feasibility study in 30 patients. Ann Surg. 2000 Dec;232(6):753-62. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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: — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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: 10.1 — View Citation

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

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. — View Citation

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. Ep — View Citation

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. Review. — View Citation

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; disc — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative complications	hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.	Duration hospitalization(an expected average of 7 days)