Hepatic Malignant Tumors, Pancreatic Cancer
Conditions
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.
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.
Interventions
PROCEDUREIRE 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.
DEVICEUltrasound
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological assessment | 1 month | CT scan will be performed. Tumor response will be assessed using RECIST criteria. |
Countries
Hong Kong
Outcome results
None listed