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Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02332551
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.

Condition or disease Intervention/treatment Phase
Hepatic Carcinoma Device: NanoKnife Not Applicable

Detailed Description:
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time,Irreversible electroporation(IRE),which was applied with a novel ablation technology, can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2025

Arm Intervention/treatment
Experimental: NanoKnife IRE System
90 pulses of 70 microseconds each in duration will be administered per electrode pair
Device: NanoKnife
Irreversible electroporation (IRE) is a new, minima-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and the gallbladder .
Other Name: IRE

No Intervention: Control



Primary Outcome Measures :
  1. Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. [ Time Frame: 30 days (+/- 3 days) post treatment ]

Secondary Outcome Measures :
  1. Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. [ Time Frame: Immediately post treatment to 2 years post treatment ]

Other Outcome Measures:
  1. Progress free survival(PFS) [ Time Frame: 24months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
  • Tumor from gallbladder is <0.5 cm
  • not suitable for surgical resection or transplantation,
  • have at least one, but less than or equal to 3 tumors,
  • of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
  • Child-Pugh class A,B
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • American Society of Anaesthesiologists (ASA) score ≤ 3,
  • a prothrombin time ratio > 50%,
  • platelet count > 80x109/L,
  • ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
  • are able to comprehend and willing to sign the written informed consent form (ICF),
  • have a life expectancy of at least 3 months.

Exclusion Criteria:

  • eligible for surgical treatment or transplantation for HCC,
  • Hepatic carcinoma developed on an already transplanted liver,
  • cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
  • any active implanted device (eg Pacemaker),
  • women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  • have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

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): NCT02332551


Contacts
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Contact: Lizhi l Niu, PHD 8615989278151 niuboshi@fudahospital.com
Contact: Feng l Jiang, M.D 8615989278151 niuboshi@fudahospital.com

Locations
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China, Guangdong
中国 Recruiting
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi l Niu, PHD FUDA Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02332551    
Other Study ID Numbers: JF-20141229
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Liver Diseases