Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy

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

Detailed Description
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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.

Official Title
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Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy

Conditions
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Hepatic Malignant Tumors, Pancreatic Cancer

Intervention / Treatment
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* Procedure: IRE treatment
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for hepatic malignancy: Signed informed consent by patient Age above 18 years Child-Pugh A or B cirrhosis Eastern Cooperative Oncology Group performance (ECOG) score 2 or below No serious concurrent medical illness 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 Inoperable HCC due to patient or tumor factors, without extra-hepatic involvement on Chest X-ray (CXR) and CT Massive expansive tumor type of HCC with measurable lesion on CT Recurrent intrahepatic HCC after surgical resection or local ablation Metastatic liver tumor with well-defined margin Tumor size <= 3cm in largest dimension Tumor number <= 3 Inclusion criteria for pancreatic malignancy: Signed informed consent by patient Age older than 18 years. Any kind of histologically or radiologically diagnosed malignant pancreatic tumor. Tumor size <= 3cm in largest dimension 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 Locally recurrent pancreatic tumor after surgical resection Karnofsky's performance status of 50% or greater. Life expectancy greater than 3 months. Normal coagulation profile (INR <1.5; platelet count >50 10^9/L). Willingness and ability to complete follow-up interviews and imaging investigations following the treatment. Exclusion Criteria: Exclusion criteria for hepatic malignancy: History of prior malignancy except on the condition that the patient has been disease free for ≥3 years Concurrent ischemic heart disease or heart failure Biliary obstruction not amenable to percutaneous drainage Child-Pugh C cirrhosis Intractable ascites not controllable by medical therapy History of variceal bleeding within last 3 months; serum total bilirubin level > 50 umol/L Serum albumin level < 25g/L INR > 1.5, platelet count <50 10^9/L Infiltrative or diffuse tumor Hepatic vein tumor thrombus Pregnancy Cardiac arrhythmia Uncontrolled hypertension Exclusion Criteria for pancreatic malignancy: Patient has active infection. Patient has bleeding tendency. Presence of portal vein thrombus. Tumour size of greatest dimension >3cm. Tumor with ill defined infiltrative margin. The tumor has invaded the duodenal wall. Presence of distant metastasis Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia). Pregnancy Cardiac arrhythmia Uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IRE treatment<br>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<br>* 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.<br>Device: Ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological assessment | CT scan will be performed. Tumor response will be assessed using RECIST criteria. | 1 month |