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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01335945
• Other study ID #: CUC10-PAN09
• Status: Terminated
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: January 2015

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Cryoablation
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	The Research Foundation of State University New York	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Patiutko IuI, Barkanov AI, Kholikov TK, Lagoshnyi AT, Li LI, Samoilenko VM, Afrikian MN, Savel'eva EV. [The combined treatment of locally disseminated pancreatic cancer using cryosurgery]. Vopr Onkol. 1991;37(6):695-700. Russian. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of abdominal pain relief	Measured from the cryoablation procedure to the return of the abdominal pain	3 Months
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure	Subjects will answer questions regarding their satisfaction.	3 Months
Secondary	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