CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.
CUC10-PAN09 is a Supportive Care, Phase 1 multicenter, prospective, single arm study with subjects serving as their own control. This study is to enroll patients who will undergo cryoablation of the Celiac Plexus. Subjects will be followed for 3 months post their cryoablation procedure. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
Karmanos Cancer Institute
Detroit, Michigan, United States
The Research Foundation of State University New York
Stony Brook, New York, United States
University Hospitals
Cleveland, Ohio, United States
Abdominal pain reduction following cryoablation of the celiac plexus
Measured by the average difference of pre- and post-treatment worst pain in the last 24 hours (baseline), within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory (BPI) Scale
Time frame: 3 Months
Duration of abdominal pain relief
Measured from the cryoablation procedure to the return of the abdominal pain
Time frame: 3 Months
Cryoablation Procedure Information
Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation
Time frame: During the procedure on the procedure day (an expected average of 3 hours)
Hospital Duration
Date and time of admission and discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Difference in average pain scores
Measured from baseline to within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory Scale
Time frame: 3 Months
Percentage of subjects able to reduce analgesic medications
Measured from baseline to within 24 hours of the cryoablation procedure, 4, 8 and 12 weeks post cryoablation procedure
Time frame: 3 Months
Time to maximal epigastric/abdominal pain relief after cryoablation
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The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure
Time frame: 3 Months
Time to recurrence of epigastric/abdominal worst pain at or above baseline
Measured worst pain score in the 12 week follow-up period as measured on a numeric 0-10 Brief Pain Inventory Scale
Time frame: 3 Months
Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure
Subjects will answer questions regarding their satisfaction.
Time frame: 3 Months
Safety assessment
The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure
Time frame: 30 Days post cryoablation