Pain, Pancreatic Cancer
Conditions
Keywords
Cryoablation, Cryotherapy, Cryosurgery, Pancreas, Pancreatic Cancer, Celiac Plexus, Pain, Abdominal pain
Brief summary
CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.
Detailed description
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).
Interventions
PROCEDURECryoablation
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 18 years old * Subject has unresectable or inoperable pancreatic carcinoma as determined by CT or MRI * Subject's epigastric/abdominal 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) on the BPI despite pharmaceutical pain management * ECOG of 0-3 * Platelet count \>50,000 * INR \<1.5
Exclusion criteria
* Subject's life expectancy is \<3 months * Subject has current neutropenia (ANC \<1000) * Subject unable to undergo CT or MRI * Subject had previous ETOH neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening * Subject had surgery \<4 weeks from screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain reduction following cryoablation of the celiac plexus | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | 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 |
| Duration of abdominal pain relief | 3 Months | Measured from the cryoablation procedure to the return of the abdominal pain |
| Cryoablation Procedure Information | 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 | 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 | 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 | 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 | 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 | 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 | 3 Months | Subjects will answer questions regarding their satisfaction. |
Countries
United States
Outcome results
None listed