Clinical trial · Interventional
A Pilot Study of IRE for Resectable Pancreatic Cancer
A Pilot Study of Irreversible Electroporation for the Treatment of Upfront Resectable Pancreatic Cancer in the Head of the Pancreas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We have been unable to secure funding. Now we are in the middle of a pandemic.
Summary
Brief summary (as posted)
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. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma Resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible Electroporation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- All patients in this pilot study are in the same group. All receive Irreversible Electroporation.
- interventionNames
- Procedure: Irreversible Electroporation
Primary outcomes (2)
- measure
- Disease Free Survival
- timeFrame
- 5 years
- description
- Disease Free Survival
- measure
- Complications
- timeFrame
- 3 months
- description
- recorded and classified
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy * Subjects who are medically unfit to receive a general anesthetic. * Patients with cardiac arrhythmia other than rate controlled atrial fibrillation. * Tumors greater than 3 cm. * Unresectable or locally advanced pancreatic cancer. * 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.
References
Publications (0)
Data not yet available