Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

September 1, 2021 updated by: Fuda Cancer Hospital, Guangzhou

A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510665
        • 中国

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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 Names:
  • IRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days (+/- 3 days) post treatment

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Progress free survival(PFS)
Time Frame: 24months
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Investigators

  • Study Chair: Lizhi l Niu, PHD, Fuda Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JF-20141229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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