Hepatocellular CarcinomaNCT02243384
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
A study testing Laparoscopic Hepatectomy and Radiofrequency Ablation in people with Hepatocellular Carcinoma, run by ChenJian at 1 site in China.
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. 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?
- Laparoscopic Hepatectomy and Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2014to 1 Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- 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%;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Laparoscopic Hepatectomy, Radiofrequency Ablation
- Keywords
- Early Hepatocellular Carcinoma, Laparoscopic Hepatectomy, Radiofrequency Ablation, Micrometastases
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Micrometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic HepatectomyProcedure or surgery
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 AblationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Hepatectomy | Experimental | Laparoscopic Hepatectomy Receives: Procedure: Laparoscopic Hepatectomy |
| Radiofrequency Ablation | Active comparator | Radiofrequency Ablation Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
postoperative complications
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Measured: Duration hospitalization(an expected average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study start1 Sep 2014
- Primary completion1 Jan 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChenJian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ChenJian, Southwest Hospital, China
- Investigators
- Jian Chen, Study chair, Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243384
- Sponsor's protocol ID
- chenjian-01
- Status last verified
- May 2022
- First submitted
- 15 Sep 2014
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
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 19383082Bruix 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 21374666Jarnagin 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 20590903Zimmerman 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 18283144Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.
PubMed 1833688Kobayashi 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 24368662Zhou 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 21259071Nguyen 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 21079109Cherqui 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 11088070Otsuka 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 19652902Ishizawa 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 22968066Dagher 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 20610244Livraghi 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 21377584Lau 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 19106671Mulier 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02243384
- Acronym / sponsor ID
- chenjian-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Early Hepatocellular Carcinoma, Laparoscopic Hepatectomy, Radiofrequency Ablation, Micrometastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ChenJianUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Hepatectomy | Experimental | Procedure: Laparoscopic HepatectomyLaparoscopic Hepatectomy |
| Radiofrequency Ablation | Active comparator | Procedure: Radiofrequency AblationRadiofrequency Ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic HepatectomyA 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 | Procedure or surgery | Laparoscopic Hepatectomy |
| Radiofrequency AblationA 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 | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Survival rate
Time frame: 5 years
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.
1 secondary outcome
postoperative complications
Time frame: Duration hospitalization(an expected average of 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Results publication: PubMed 19383082Amarapurkar 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.
- Results publication: PubMed 21374666Bruix 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.
- Results publication: PubMed 20590903Jarnagin 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.
- Results publication: PubMed 18283144Zimmerman 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.
- Results publication: PubMed 1833688Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.
- Results publication: PubMed 24368662Kobayashi 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.
- Results publication: PubMed 21259071Zhou 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.
- Results publication: PubMed 21079109Nguyen 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.
- Results publication: PubMed 11088070Cherqui 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.
- Results publication: PubMed 19652902Otsuka 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.
- Results publication: PubMed 22968066Ishizawa 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.
- Results publication: PubMed 20610244Dagher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Chen study chair
Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Hepatectomy and Radiofrequency Ablation in people with Hepatocellular Carcinoma, run by ChenJian 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 2 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival rate (time frame: 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 NCT02243384, which also lists 24 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 2 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.