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

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

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).

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