Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
- Conditions
- PainPancreatic Cancer
- Interventions
- Procedure: Cryoablation
- Registration Number
- NCT01335945
- Lead Sponsor
- Boston Scientific Corporation
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cryoablation Cryoablation Freezing of the celiac plexus
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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.
Duration of abdominal pain relief 3 Months Measured from the cryoablation procedure to the return of the abdominal pain
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
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
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
Trial Locations
- Locations (3)
The Research Foundation of State University New York
🇺🇸Stony Brook, New York, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States