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Clinical Trial Record

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Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy

2013-07-22

2020-09-23

2020-09-23

11

Study Overview

Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy

The objectives of this study are to study the safety and effect of IRE as a treatment for inoperable hepatic and pancreatic malignancy.

Irreversible electroporation (IRE) is a form of non-thermal local ablation for solid tumors, it induces apoptosis of tumor cells by creating irreversible damage in the cell membrane using electric current. The use of thermal ablation for tumors adjacent to major blood vessels is not advisable because the "heat-sink effect" owing to blood vessels render the thermal treatment not effective. On the other hand, application of thermal ablation to a tumor adjacent to blood vessels or bile ducts will cause thermal damage to these structures. It has been shown in animal experiments that IRE is effective in causing cell death while blood vessels, bile ducts, and nerves in the vicinity are preserved. Early evidence of clinical studies has shown that IRE is a reasonably safe and effective treatment for pancreatic and hepatic tumors.

  • Hepatic Malignant Tumors
  • Pancreatic Cancer
  • PROCEDURE: IRE treatment
  • DEVICE: Ultrasound
  • VIR-13-06

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 Registration Dates Results Reporting Dates Study Record Updates

2016-06-30  

N/A  

2022-10-19  

2016-07-01  

N/A  

2022-10-21  

2016-07-04  

N/A  

2022-10  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: IRE treatment

Irreversible electroporation (IRE) is a form of non-thermal local ablation for solid tumors, it induces apoptosis of tumor cells by creating irreversible damage in the cell membrane using electric current. IRE treatment is given for a therapeutic purpose

PROCEDURE: IRE treatment

  • The treatment procedure is carried out percutaneously under ultrasound or CT guidance, or using laparoscopic or laparotomy approach when the lesion is close to hollow viscera or abdominal wall, with the patient under general anaesthesia. Insulated needle

DEVICE: Ultrasound

Primary Outcome MeasuresMeasure DescriptionTime Frame
Radiological assessmentCT scan will be performed. Tumor response will be assessed using RECIST criteria.1 month
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Inclusion criteria for hepatic malignancy:

    • 1. Signed informed consent by patient 2. Age above 18 years 3. Child-Pugh A or B cirrhosis 4. Eastern Cooperative Oncology Group performance (ECOG) score 2 or below 5. No serious concurrent medical illness 6. Histologically or cytologically proven malignant liver tumor, or lesions of size 1 to 2 cm, with typical features of hepatocellular carcinoma (HCC) on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with Apha Fetal Protein (AFP) level > 200 ug/L 7. Inoperable HCC due to patient or tumor factors, without extra-hepatic involvement on Chest X-ray (CXR) and CT 8. Massive expansive tumor type of HCC with measurable lesion on CT 9. Recurrent intrahepatic HCC after surgical resection or local ablation 10. Metastatic liver tumor with well-defined margin 11. Tumor size <= 3cm in largest dimension 12. Tumor number <= 3
  • Inclusion criteria for pancreatic malignancy:

    • 1. Signed informed consent by patient 2. Age older than 18 years. 3. Any kind of histologically or radiologically diagnosed malignant pancreatic tumor. 4. Tumor size <= 3cm in largest dimension 5. Surgical treatment is considered not an option because of patient factors or tumor factors, such as those with vascular encasement or regional lymph node metastasis 6. Locally recurrent pancreatic tumor after surgical resection 7. Karnofsky's performance status of 50% or greater. 8. Life expectancy greater than 3 months. 9. Normal coagulation profile (INR <1.5; platelet count >50 10^9/L). 10. Willingness and ability to complete follow-up interviews and imaging investigations following the treatment.
    Exclusion Criteria:

  • Exclusion criteria for hepatic malignancy:

    • 1. History of prior malignancy except on the condition that the patient has been disease free for ≥3 years 2. Concurrent ischemic heart disease or heart failure 3. Biliary obstruction not amenable to percutaneous drainage 4. Child-Pugh C cirrhosis 5. Intractable ascites not controllable by medical therapy 6. History of variceal bleeding within last 3 months; serum total bilirubin level > 50 umol/L 7. Serum albumin level < 25g/L 8. INR > 1.5, platelet count <50 10^9/L 9. Infiltrative or diffuse tumor 10. Hepatic vein tumor thrombus 11. Pregnancy 12. Cardiac arrhythmia 13. Uncontrolled hypertension
  • Exclusion Criteria for pancreatic malignancy:

    • 1. Patient has active infection. 2. Patient has bleeding tendency. 3. Presence of portal vein thrombus. 4. Tumour size of greatest dimension >3cm. 5. Tumor with ill defined infiltrative margin. 6. The tumor has invaded the duodenal wall. 7. Presence of distant metastasis 8. Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia). 9. Pregnancy 10. Cardiac arrhythmia 11. Uncontrolled hypertension

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: Simon Yu, Professor, Chinese University of Hong Kong

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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