Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer

Study Overview
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Brief Summary
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CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.

Detailed Description
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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).

Official Title
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Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer

Conditions
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Pain, Pancreatic Cancer

Intervention / Treatment
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* Procedure: Cryoablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cryoablation<br>Freezing of the celiac plexus | Procedure: Cryoablation<br>* All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.<br>* Other names: IceSeed cryoablation needles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of abdominal pain relief | Measured from the cryoablation procedure to the return of the abdominal pain | 3 Months | 
| Cryoablation Procedure Information | Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation | During the procedure on the procedure day (an expected average of 3 hours) | 
| Hospital Duration | Date and time of admission and discharge | 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 | 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 | 3 Months | 
| Time to maximal epigastric/abdominal pain relief after 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 | 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 | 3 Months | 
| Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure | Subjects will answer questions regarding their satisfaction. | 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 | 30 Days post cryoablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation, Cryotherapy, Cryosurgery, Pancreas, Pancreatic Cancer, Celiac Plexus, Pain, Abdominal pain