Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02898649|
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : February 15, 2019
Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer patients is diagnosed in operable status. So, most of patients could not be treated with curative resection.
Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only less than 30% of patients showed treatment response, and median survival of LAPC patient was only 9 months. Thus, more effective treatment modality is needed for LAPC patients.
Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent and hence lethal nanopores in the cell membrane, to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis and has tissue selectivity, so adjacent tissue or vascular structures can be preserved.
Several clinical trials using IRE were performed to liver, kidney or lung cancer patients. We will operate IRE procedure to LAPC patients who were previously received standard therapy but showed no response, using NanoKnife IRE device. We will investigate treatment response and safety of IRE.
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Pancreatic Cancer||Device: Irreversible electroporation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
The intervention group
Device: Irreversible electroporation
IRE is operated to tumor under laparotomy or CT-guided percutaneous approach. Unipolar (19G) or bipolar (16G) electrode probe is inserted to around tumor. After insertion of probe, short duration (70-90㎲) of electric current (25~45A) is generated by IRE device (NanoKnife IRE device, AngioDynamics, Queens bury, New York). It is possible to obtain a three-dimensional ablation zone using multiple electrode. IRE can cause apoptosis of tumor cells, without adjacent tissue damage.
- Overall survival [ Time Frame: from 1 month to 3 month ]Overall survival is calculated from the date of informed consent acquisition until the date of death.
- Safety (frequency of procedure-related complication and death) [ Time Frame: from 1 month to 3 month ]Safety is evaluated by the frequency of procedure-related complication and death.
- Time to progression [ Time Frame: within 1 year ]
- Tumor control [ Time Frame: within 1 year ]
- Pain control [ Time Frame: within 1 year ]
- Change in CA 19-9 [ Time Frame: within 1 year ]
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): NCT02898649
|Contact: Seung Min Bang, MD||+82 2 2228 1995||BANG7028@yuhs.ac|
|Korea, Republic of|
|Yonsei university of medical center||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Seung Min Bang, MD +82 2 2228 1995 BANG7028@yuhs.ac|