Clinical trial NCT01335945: Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
Official title: Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pain
Pancreatic Cancer
Keywords: Cryoablation
Cryotherapy
Cryosurgery
Pancreas
Pancreatic Cancer
Celiac Plexus
Pain
Abdominal pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-04-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal pain reduction following cryoablation of the celiac plexus
timeFrame: 3 Months
Secondary outcomes:
measure: Duration of abdominal pain relief
timeFrame: 3 Months
measure: Cryoablation Procedure Information
timeFrame: During the procedure on the procedure day (an expected average of 3 hours)
measure: Hospital Duration
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Difference in average pain scores
timeFrame: 3 Months
measure: Percentage of subjects able to reduce analgesic medications
timeFrame: 3 Months
measure: Time to maximal epigastric/abdominal pain relief after cryoablation
timeFrame: 3 Months
measure: Time to recurrence of epigastric/abdominal worst pain at or above baseline
timeFrame: 3 Months
measure: Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure
timeFrame: 3 Months
measure: Safety assessment
timeFrame: 30 Days post cryoablation
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Stony Brook
country: United States
facility: The Research Foundation of State University New York
state: New York
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
name: David D Childs, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.3748/wjg.v13.i26.3575.
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.
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.
citation: 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. doi: 10.1067/msy.2002.121231.
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. doi: 10.1001/jama.291.9.1092.
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. doi: 10.1111/j.1572-0241.2006.00967.x. Epub 2006 Nov 13.
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. doi: 10.1016/j.ejso.2005.03.012.