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Trial record 4 of 23 for:    Pancreatic Cancer | ( Map: Hong Kong )

Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy (IRE)

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ClinicalTrials.gov Identifier: NCT02822716
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Simon Yu, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Hepatic Malignant Tumors Pancreatic Cancer Procedure: IRE treatment Device: Ultrasound Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy
Study Start Date : November 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 as a non-surgical alternative to those patients with an inoperable condition.
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 electrodes, will be placed in the treatment areas under ultrasound or CT guidance. The tumor lesion is identified, measured, and located by ultrasound or CT. Electrical current is administered in pulses with electrocardiographic synchronization to reduce the risk of cardiac arrhythmia.

Device: Ultrasound



Primary Outcome Measures :
  1. Radiological assessment [ Time Frame: 1 month ]
    CT scan will be performed. Tumor response will be assessed using RECIST criteria.



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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:

  • 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

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): NCT02822716


Contacts
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Contact: Carmen Wong (852) 3505 3210 carmenwongsp@cuhk.edu.hk
Contact: Pui Man Chong (852) 3505 3211 siuman@cuhk.edu.hk

Locations
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Hong Kong
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Carmen Wong    (852) 3505 3210    carmenwongsp@cuhk.edu.hk   
Contact: Sally Lee    (852) 3505 2046    sallylee@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Simon Yu, Professor Chinese University of Hong Kong

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Responsible Party: Simon Yu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02822716     History of Changes
Other Study ID Numbers: VIR-13-06
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms