Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy

Pancreatic Cancer Clinical Trial

— IRE  

Official title:

Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02822716
• Other study ID #: VIR-13-06
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2013
• Est. completion date: September 23, 2020

Study information

• Verified date: October 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Malignant Tumors
• Neoplasms
• Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological assessment	CT scan will be performed. Tumor response will be assessed using RECIST criteria.	1 month