A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02841436|
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Device: Irreversible Electroporation (IRE) System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 16, 2014|
|Actual Study Completion Date :||May 27, 2020|
Experimental: irreversible electroporation (IRE)
IRE (AngioDynamics, NY) To use 2 to 6 unipolar electrodes in a predetermined grid pattern. 90 pulses of 2,000 - 3,000 V were applied with a pulse generator (AngioDynamics, NY) across the gap between the electrodes for 100 microseconds (0.1 msec) per each ablation.
Device: Irreversible Electroporation (IRE) System
- Tumor response [ Time Frame: 1 month after treatment ]Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) evaluation [ Time Frame: one to two years ]Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
- Haematology test [ Time Frame: one to two years ]complete white blood cell count with differential, red blood cell count, hemoglobin, hematocrit, and platelets
- Tumor marker measurement [ Time Frame: one to two years ]measure the change of tumor marker such as carcinoembryonic antigen (CEA)
- Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation [ Time Frame: one to two years ]Subjects will still be followed-up in the event of disease progression in order to document overall survival, a secondary endpoint.
- Review concomitant medications [ Time Frame: one to two years ]Use of medications will be reviewed and recorded
- Assess for presence of adverse event [ Time Frame: one to two years ]An adverse event assessment will be performed
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): NCT02841436
|Principal Investigator:||Kai-Wen Huang, PhD||National Taiwan University Hospital|