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2012-11
2014-06-16
2020-05-27
7
NCT02841436
National Taiwan University Hospital
National Taiwan University Hospital
INTERVENTIONAL
A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer
Pancreatic cancers is one the most important malignancies with highest mortality in the world. The prognosis of these patients is very poor. Although some patients with early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of patients present with locally advanced or metastatic status are inoperable. Patients in this late status usually are recommended to receive palliative bypass operation such as choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However, the main drawback of RFA is its side effect to damage adjacent structure such as bile duct, and the tumors located adjacent to vessels could not be ablated well.
Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor effect does not result from thermotherapy, so is also not diminished by adjacent vessels. Several pre-clinical and clinical studies have already demonstrated IRE is a safe and effective treatment, and the adjacent tissue such as vessels and ductal structures will be spared. Recently, IRE had been used to treat pancreatic cancer successfully, and the safety is satisfactory. The system has been approved as safe by the European Union (EU) in 2008 and received Food and Drug Administration (FDA) approval in 2010. However, there are still few experiences in using IRE for tumor ablation in Taiwan. In this study, the investigators will perform IRE for inoperable patients with locally advanced pancreatic cancers. They will receive IRE during the operation of palliative bypass operation including choledochojejunostomy and/or gastrojejunostomy. The investigators will evaluate the potential side effect and ablate effect of tumors, and also follow-up the patients for 2 years to evaluate the overall survival. The investigators will appraisal the clinical feasibility and advantage of the system by this study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-06-27 | N/A | 2020-07-02 |
2016-07-19 | N/A | 2020-07-07 |
2016-07-22 | N/A | 2020-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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 | DEVICE: Irreversible Electroporation (IRE) System |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Tumor response | Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI). | 1 month after treatment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Eastern Cooperative Oncology Group (ECOG) evaluation | Complete an Eastern Cooperative Oncology Group (ECOG) evaluation | one to two years |
| Haematology test | complete white blood cell count with differential, red blood cell count, hemoglobin, hematocrit, and platelets | one to two years |
| Tumor marker measurement | measure the change of tumor marker such as carcinoembryonic antigen (CEA) | one to two years |
| Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation | Subjects will still be followed-up in the event of disease progression in order to document overall survival, a secondary endpoint. | one to two years |
| Review concomitant medications | Use of medications will be reviewed and recorded | one to two years |
| Assess for presence of adverse event | An adverse event assessment will be performed | one to two years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
