A Pilot Study of IRE for Resectable Pancreatic Cancer
Key facts
- Who runs it
- University of Saskatchewan
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 1 Oct 2021
- Ended
- Jan 2025
- Type of study
- Interventional
- Treatments tested
- Irreversible Electroporation
- Record updated
- 6 May 2021
- Why it stopped
- We have been unable to secure funding. Now we are in the middle of a pandemic.
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Biopsy-proven pancreatic adenocarcinoma of the head of the pancreas
- Age 18 to 75
- Ability to understand and the willingness to sign a written informed consent document
Who cannot take part
- Patients with cardiac arrhythmia other than rate controlled atrial fibrillation
- Unresectable or locally advanced pancreatic cancer
- Pregnancy
- Subjects who are medically unfit to receive a general anesthetic
- Tumors greater than 3 cm
- Patients with a high suspicion for lymph node metastasis or peripancreatic pathologic (> 1 cm) lymph nodes on imaging
- Metastatic pancreatic carcinoma, including unexpected peritoneal or liver metastases discovered at the time of laparotomy for planned IRE
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The operation to remove certain pancreatic cancers (Whipple procedure), even in 2017, remains one of the most complicated surgeries done in the abdomen. It carries a 50% chance of a complication, even in the world's largest pancreatic surgery centres.
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Saskatchewan is one of only two centres in Canada to have a promising new technology called Irreversible Electroporation (IRE) (NanoKnife®) available to our patients for the ablation (destruction) of cancers. IRE is different from other ablation treatments, including heat and even radiation, in that with IRE no heat is generated and there is minimal, if any, damage to nearby blood vessels, bowel, and ducts. Thus far, IRE has only been used as a "last resort" in cases where the pancreatic cancer cannot be removed with surgery, yet many patients whose tumor could likely be removed with a 'Whipple' have expressed a preference to undergo IRE instead of the Whipple procedure.
Our main research questions are: In comparison to Whipple procedure, is IRE an effective treatment of pancreatic cancer, and are complications reduced? Is IRE cost-effective? Based on the cases we have done and published series of IRE for stage III pancreatic cancer, we believe that IRE will be effective and safe in treating lesser stage (I and II) tumors in our proposed study.
This will be a pilot study of 12-15 patients, and all recruited patients will receive the IRE treatment and then be followed for up to 5 years for quality of life, recurrence, survival, and cost.
The group in the trial
- Study groupTreatment being tested
All patients in this pilot study are in the same group. All receive Irreversible Electroporation.
Treatment: Irreversible Electroporation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Study of Irreversible Electroporation for the Treatment of Upfront Resectable Pancreatic Cancer in the Head of the Pancreas
- Record updated
- 6 May 2021