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
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Malignant Tumors Pancreatic Cancer||Procedure: IRE treatment Device: Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Radiological assessment [ Time Frame: 1 month ]CT scan will be performed. Tumor response will be assessed using RECIST criteria.
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
|Contact: Carmen Wong||(852) 3505 email@example.com|
|Contact: Pui Man Chong||(852) 3505 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Sally Lee (852) 3505 2046 firstname.lastname@example.org|
|Principal Investigator:||Simon Yu, Professor||Chinese University of Hong Kong|