Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Saskatchewan
With
* 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).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
