A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer

July 2, 2020 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 1 month after treatment
Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
1 month after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eastern Cooperative Oncology Group (ECOG) evaluation
Time Frame: one to two years
Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
one to two years
Haematology test
Time Frame: one to two years
complete white blood cell count with differential, red blood cell count, hemoglobin, hematocrit, and platelets
one to two years
Tumor marker measurement
Time Frame: one to two years
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
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.
one to two years
Review concomitant medications
Time Frame: one to two years
Use of medications will be reviewed and recorded
one to two years
Assess for presence of adverse event
Time Frame: one to two years
An adverse event assessment will be performed
one to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

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 Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201210008DIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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