Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
Study Details
Study Description
Brief Summary
CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Cryoablation Freezing of the celiac plexus |
Procedure: Cryoablation
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must be at least 18 years old
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Subject has unresectable or inoperable pancreatic carcinoma as determined by CT or MRI
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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
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ECOG of 0-3
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Platelet count >50,000
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INR <1.5
Exclusion Criteria:
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Subject's life expectancy is <3 months
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Subject has current neutropenia (ANC <1000)
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Subject unable to undergo CT or MRI
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Subject had previous ETOH neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening
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Subject had surgery <4 weeks from screening
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
2 | The Research Foundation of State University New York | Stony Brook | New York | United States | 11794 |
3 | University Hospitals | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: David D Childs, MD,
Study Documents (Full-Text)
None provided.More Information
Publications
- Kovach SJ, Hendrickson RJ, Cappadona CR, Schmidt CM, Groen K, Koniaris LG, Sitzmann JV. Cryoablation of unresectable pancreatic cancer. Surgery. 2002 Apr;131(4):463-4.
- Kruse EJ. Palliation in pancreatic cancer. Surg Clin North Am. 2010 Apr;90(2):355-64. doi: 10.1016/j.suc.2009.12.004. Review.
- Michaels AJ, Draganov PV. Endoscopic ultrasonography guided celiac plexus neurolysis and celiac plexus block in the management of pain due to pancreatic cancer and chronic pancreatitis. World J Gastroenterol. 2007 Jul 14;13(26):3575-80. Review.
- Patiutko IuI, Barkanov AI, Kholikov TK, Lagoshnyĭ AT, Li LI, Samoĭlenko VM, Afrikian MN, Savel'eva EV. [The combined treatment of locally disseminated pancreatic cancer using cryosurgery]. Vopr Onkol. 1991;37(6):695-700. Russian.
- Stefaniak T, Basinski A, Vingerhoets A, Makarewicz W, Connor S, Kaska L, Stanek A, Kwiecinska B, Lachinski AJ, Sledzinski Z. A comparison of two invasive techniques in the management of intractable pain due to inoperable pancreatic cancer: neurolytic celiac plexus block and videothoracoscopic splanchnicectomy. Eur J Surg Oncol. 2005 Sep;31(7):768-73.
- Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9.
- Xiong LL, Hwang JH, Huang XB, Yao SS, He CJ, Ge XH, Ge HY, Wang XF. Early clinical experience using high intensity focused ultrasound for palliation of inoperable pancreatic cancer. JOP. 2009 Mar 9;10(2):123-9.
- Yan BM, Myers RP. Neurolytic celiac plexus block for pain control in unresectable pancreatic cancer. Am J Gastroenterol. 2007 Feb;102(2):430-8. Epub 2006 Nov 13. Review.
- CUC10-PAN09