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Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors

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ClinicalTrials.gov Identifier: NCT02010801
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70%to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely.

Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor effect does not result from thermotherapy, so is also not diminished by adjacent vessels. Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010. However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study, the investigators will perform intraoperative IRE for the patients with liver cancers who are scheduled to receive hepatectomy in our hospital, and the investigators will evaluate the ablate effect of tumors on specimens, and the effect of adjacent vessels. The investigators will appraisal the clinical feasibility and advantage of the system by this study.


Condition or disease Intervention/treatment Phase
Malignant Liver Tumors Procedure: irreversible electroporation Device: nanoknife AngioDynamics US Ltd Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: IRE for tumor before tumor resection Procedure: irreversible electroporation
Other Name: nanoknife

Device: nanoknife AngioDynamics US Ltd



Primary Outcome Measures :
  1. Complete treatment [ Time Frame: 1 month later ]

Secondary Outcome Measures :
  1. adverse effect [ Time Frame: one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The diagnosis of HCC or other cancers with hepatic metastatic with pathologic proven.
  • The diagnosis of HCC will be made by pathology / cytology or according to the AASLD(2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either 4-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
  • Suitable for surgical resection, but the distance between tumors and preserved vessels is less than 5 mm. Adequate safe margin can not be obtained.
  • There are at least one tumor, but less than or equal to 3 tumors,
  • Each tumor must be ≤ 5 cm in diameter,
  • Child-Pugh class A-B,
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • American Society of Anaesthesiologists (ASA) score ≤ 3,
  • Platelet count ≥ 100 K/Μl
  • Total bilirubin ≦ 2 mg/dL
  • ALT and AST < 5 x upper limit of normal
  • PT-INR ≦ 2.0, or PT < 6 seconds above control
  • Serum creatinine ≦ 1.5 x upper limit of normal
  • Prior Informed Consent Form
  • Life expectancy of at least 3 months.

Exclusion Criteria:

  • Congestive heart failure >New York Heart Association (NYHA) class 2
  • Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
  • Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
  • Uncontrolled hypertension
  • Any active metal implanted device (eg Pacemaker),
  • Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  • Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ IRE System,
  • Known history of HIV infection
  • Concurrent primary extrahepatic cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010801


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-Wen Huang, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02010801     History of Changes
Other Study ID Numbers: 201010036D
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by National Taiwan University Hospital:
hepatocellular carcinoma
irreversible electroporation
liver cancer

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases