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A Clinical Research About Using Irreversible Electroporation to Treat 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841436
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: Irreversible Electroporation (IRE) System Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 ablation.
Device: Irreversible Electroporation (IRE) System



Primary Outcome Measures :
  1. Tumor response [ Time Frame: 1 month after treatment ]
    Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).


Secondary Outcome Measures :
  1. Eastern Cooperative Oncology Group (ECOG) evaluation [ Time Frame: one to two years ]
    Complete an Eastern Cooperative Oncology Group (ECOG) evaluation

  2. Haematology test [ Time Frame: one to two years ]
    complete white blood cell count with differential, red blood cell count, hemoglobin, hematocrit, and platelets

  3. Tumor marker measurement [ Time Frame: one to two years ]
    measure the change of tumor marker such as carcinoembryonic antigen (CEA)

  4. 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.

  5. Review concomitant medications [ Time Frame: one to two years ]
    Use of medications will be reviewed and recorded

  6. Assess for presence of adverse event [ Time Frame: one to two years ]
    An adverse event assessment will be performed



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for this study:

  1. Locally advanced pancreatic cancer is defined as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic cancer -described as arterial encasement of either the celiac axis or superior mesenteric artery or both.
  2. Biliary tract or intestine is compromised by tumor, palliative bypass operation (hepaticojejunostomy and/or gastrojejunostomy) is considered to be performed.
  3. Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  4. American Society of Anaesthesiologists (ASA) score ≤ 3,
  5. Adequate bone marrow, liver and renal function. Platelet count ≥ 100 K/Μl. Total bilirubin ≦ 5 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 1.5 x upper limit of normal
  6. Prior Informed Consent Form
  7. Life expectancy of at least 3 months.

Exclusion Criteria:

Patients presenting with any of the following will not be enrolled into this study:

  1. History of cardiac disease:
  2. Congestive heart failure >New York Heart Association (NYHA) class 2
  3. Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
  4. Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
  5. Uncontrolled hypertension
  6. Any active metal implanted device (eg Pacemaker),
  7. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  8. Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the IRE System,
  9. Known history of human immunodeficiency virus (HIV) infection
  10. Patients with resectable lesions.

Information from the National Library of Medicine

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


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-Wen Huang, PhD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02841436    
Other Study ID Numbers: 201210008DIC
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
irreversible electroporation
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases