Oncology

A Clinical Study for Stage III Pancreatic Cancer

You’ve just been diagnosed with pancreatic cancer. You are overwhelmed. You are frightened. But you are not alone. It is your right to empower yourself and educate yourself on treatment options that are available to you. Leaning on your family and healthcare team can help you choose the right course of action for you during this difficult time.

DIRECT is a clinical study for stage III pancreatic cancer. And while, it could be a potential course of treatment for you, choosing to participate in a clinical study is a serious personal decision. Please speak with your doctor, healthcare team and/or family members about the treatment option that is best for you. 

If you have questions about DIRECT, please browse the FAQs below to better understand the study and its method of treatment. If you have additional questions, please contact our study support line at +1 (800) 584-7608.

The pancreas is a glandular organ located behind the stomach and in front of the spine. The pancreas’ function is to produce digestive enzymes and hormones that regulate blood sugar levels. Pancreatic cancer begins when abnormal, malignant (cancerous) cells form in the tissues of the pancreas.2

Pancreatic adenocarcinoma is the most common type of pancreatic cancer. Pancreatic neuroendocrine tumors (NETs) are a less common type and are discussed in Pancreatic Neuroendocrine Tumors.2

The staging system used most often for pancreatic cancer is the AJCC (American Joint Committee on Cancer) TNM system, which is based on 3 key pieces of information:3

  • The extent of the tumor (T): How large is the tumor and has it grown outside the pancreas into nearby blood vessels?
  • The spread to nearby lymph nodes (N): Has the cancer spread to nearby lymph nodes? If so, how many of the lymph nodes have cancer?
  • The spread (metastasized) to distant sites (M): Has the cancer spread to distant lymph nodes or distant organs such as the liver, peritoneum (the lining of the abdominal cavity), lungs or bones?


In stage III pancreatic cancer, most tumors are considered unresectable, or unable to be removed by surgery, and are treated with different therapies that travel through the bloodstream to reach cancer cells throughout the body.4

Irreversible Electroporation (IRE) is a technique in which electrical pulses are applied to targeted cells. This results in the formation of small holes in the cell membranes. After enough pulses are delivered to the cells, the cells initiate a process that mimics apoptosis, which leads to permanent cell death. Thus, destroying the cells.5

DIRECT is a clinical study for stage III pancreatic cancer sponsored by AngioDynamics, Inc. It is a U.S. based study that launched in the spring of 2019 and is currently enrolling qualified patients.  

The purpose of the study is to evaluate the effects of using IRE technology to treat stage III pancreatic cancer. The IRE technology used in DIRECT is known as the NanoKnife System. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

DIRECT is led by Co-Principal Investigators – Govindarajan Narayanan, MD, Chief of Interventional Oncology at Miami Cancer Institute and Robert C.G. Martin, MD, PhD, Surgical Oncology at the University of Louisville; both of whom have been using IRE technology for nearly a decade.

Support is on your side. There are plenty of ways to get involved and support the fight against pancreatic cancer by reaching out to foundations near you. Some organizations that support pancreatic cancer awareness and research include:


Pancreatic Cancer Action Network (panCAN)
The Pancreatic Cancer Action Network (PanCAN) is dedicated to fighting the world’s toughest cancer. In their urgent mission to save lives, they attack pancreatic cancer on all fronts: research, clinical initiatives, patient services and advocacy.

The American Cancer Society (ACS)
The American Cancer Society is a nationwide, community-based voluntary health organization dedicated to eliminating cancer as a major health problem. Their mission is to save lives, celebrate lives, and lead the fight for a world without cancer.

The Lustgarten Foundation
Their mission is to cure pancreatic cancer by funding scientific and clinical research, providing research information and clinical support services to patients, caregivers and individuals at high risk, and increasing public awareness and hope for those dealing with this disease.

Let’s Win! Pancreatic Cancer
Let’s Win! Pancreatic Cancer is a platform that enables doctors, scientists, and patients to share fast-breaking information on potentially life-saving pancreatic cancer treatments and clinical trials. Their goal is to inform, enable, and educate patients and caregivers.

1 Cancer Facts & Figures 2020. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annualcancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf Accessed February 26, 2020.

2 What Is Pancreatic Cancer? American Cancer Society. https://www.cancer.org/cancer/pancreatic-cancer/about/what-is-pancreatic-cancer.html. Accessed February 26, 2020.

3 Pancreatic Cancer Stages. American Cancer Society. https://www.cancer.org/cancer/pancreaticcancer/detection-diagnosis-staging/staging.html. Accessed February 26, 2020.

4 Pancreatic Cancer - Stages. Cancer.Net. https://www.cancer.net/cancer-types/pancreaticcancer/stages. Published May 23, 2018. Accessed February 26, 2020.

5 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. (2010);4(SUPPL. 1):99–104. doi: 10.5009/gnl.2010.4.S1.S99.

AngioDynamics, the AngioDynamics logo and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. GL/ON/WP/105 Rev 01 02/20