Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03337997 |
| Other study ID # |
IRE002 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
April 2021 |
| Source |
University of Saskatchewan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
- Subjects will receive a general anesthetic and will undergo a midline laparotomy and a
careful inspection to ensure no distant metastases are obvious in the peritoneal cavity.
- Ultrasound-guided IRE of the pancreatic mass will be performed by interventional
radiologist Dr. Chris Wall as per the protocol of Martin et al [ ].
- Subjects will be monitored for adverse events in the postoperative period until the time
of discharge from the hospital, typically on the 5th or 6th day after the procedure.
- Adjuvant chemotherapy is recommended following the procedure but it is not mandatory.
- Patients will be assessed and offered single agent gemcitabine or combination of
gemcitabine and capecitabine at the discretion of treating oncologists. It is
recommended that patients begin treatment within 12 weeks after the procedure.
- Specific drug reductions and management of will be made in accordance with the published
recommendations for gemcitabine or gemcitabine plus capecitabine.
- Patients will be scheduled for regular follow up and surveillance history and physical
exam by the Hepatobiliary Surgeons Group.
- The same surveillance protocol that is used after the Whipple procedure will be
followed: bloodwork at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months (complete blood count,
electrolytes, creatinine, liver enzymes, Ca 19.9) and imaging (Chest Xray and CT abdomen
at 3 months, followed by a PET scan at 6 months, CT scan at 9 and 12 months, then yearly
CT or MRI).
- For study purposes, each scan will be re-reviewed by the same two radiologists with a
goal of arriving at a consensus in each case.
- Two validated QOL questionnaires, the FACT-Hep, which is specific to hepatic and
pancreatic diseases, and the more general FACT-G questionnaire will be administered
preoperatively and at 3 and 12 months.
- Each IRE case will be matched 2:1 with patients undergoing the Whipple Procedure around
the same time (within 12 months of each other) for non-locally advanced pancreatic
cancer, matched by age +/- 5 years, gender, tumor size +/- 0.5 cm, and preoperative
chemotherapy.
- Survival curves will be analyzed using the Kaplan-Meier method, and differences between
groups will be assessed using log-rank test.
- Student's T test and the Mann-Whitney U test will be used for other comparisons between
the two groups and p<0.05 will be taken to be significant. SPSS version 24 will be used
for statistical analyses (SPSS Inc, Chicago, IL).
