Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer|
- Abdominal pain reduction following cryoablation of the celiac plexus [ Time Frame: 3 Months ]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
- Duration of abdominal pain relief [ Time Frame: 3 Months ]Measured from the cryoablation procedure to the return of the abdominal pain
- Cryoablation Procedure Information [ Time Frame: During the procedure on the procedure day (an expected average of 3 hours) ]Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation
- Hospital Duration [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]Date and time of admission and discharge
- Difference in average pain scores [ Time Frame: 3 Months ]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
- Percentage of subjects able to reduce analgesic medications [ Time Frame: 3 Months ]Measured from baseline to within 24 hours of the cryoablation procedure, 4, 8 and 12 weeks post cryoablation procedure
- Time to maximal epigastric/abdominal pain relief after cryoablation [ Time Frame: 3 Months ]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 to recurrence of epigastric/abdominal worst pain at or above baseline [ Time Frame: 3 Months ]Measured worst pain score in the 12 week follow-up period as measured on a numeric 0-10 Brief Pain Inventory Scale
- Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure [ Time Frame: 3 Months ]Subjects will answer questions regarding their satisfaction.
- Safety assessment [ Time Frame: 30 Days post cryoablation ]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
|Study Start Date:||August 2011|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Freezing of the celiac plexus
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335945
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|The Research Foundation of State University New York|
|Stony Brook, New York, United States, 11794|
|United States, Ohio|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||David D Childs, MD|