Clinical trial · Interventional
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
NCT02243384CI-TRIAL-00058857completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Hepatectomy | Procedure | — | UNRESOLVED |
| Radiofrequency Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic Hepatectomy
- description
- Laparoscopic Hepatectomy
- interventionNames
- Procedure: Laparoscopic Hepatectomy
- type
- ACTIVE_COMPARATOR
- label
- Radiofrequency Ablation
- description
- Radiofrequency Ablation
- interventionNames
- Procedure: Radiofrequency Ablation
Primary outcomes (1)
- measure
- Survival rate
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (24)
- RESULTAmarapurkar 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
- RESULTBruix 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
- RESULTJarnagin 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
- RESULTZimmerman 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
- RESULTReich 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
- RESULTKobayashi 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
- RESULTZhou 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.