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

Primary Purpose

Pain, Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Cryoablation, Cryotherapy, Cryosurgery, Pancreas, Pancreatic Cancer, Celiac Plexus, Pain, Abdominal pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karmanos Cancer Institute
  • The Research Foundation of State University New York
  • University Hospitals

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cryoablation

Arm Description

Freezing of the celiac plexus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of abdominal pain relief
Measured from the cryoablation procedure to the return of the abdominal pain
Cryoablation Procedure Information
Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation
Hospital Duration
Date and time of admission and discharge
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
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
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
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
Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure
Subjects will answer questions regarding their satisfaction.
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

Full Information

First Posted
April 13, 2011
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01335945
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment & subjects didn't survive to study end due to cancer progression.
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pancreatic Cancer
Keywords
Cryoablation, Cryotherapy, Cryosurgery, Pancreas, Pancreatic Cancer, Celiac Plexus, Pain, Abdominal pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation
Arm Type
Other
Arm Description
Freezing of the celiac plexus
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cryotherapy, Visual-ICE cryoablation system, SeedNet cryoablation system, PresIce cryoablation system, IceRod cryoablation needles, IceRod PLUS cryoablation needles, IceRod CX cryoablation needles, IceEDGE 2.4 cryoablation needles, IceSphere cryoablation needles, IceSeed cryoablation needles
Intervention Description
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
Primary Outcome Measure Information:
Title
Abdominal pain reduction following cryoablation of the celiac plexus
Description
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
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Duration of abdominal pain relief
Description
Measured from the cryoablation procedure to the return of the abdominal pain
Time Frame
3 Months
Title
Cryoablation Procedure Information
Description
Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation
Time Frame
During the procedure on the procedure day (an expected average of 3 hours)
Title
Hospital Duration
Description
Date and time of admission and discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Title
Difference in average pain scores
Description
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
Time Frame
3 Months
Title
Percentage of subjects able to reduce analgesic medications
Description
Measured from baseline to within 24 hours of the cryoablation procedure, 4, 8 and 12 weeks post cryoablation procedure
Time Frame
3 Months
Title
Time to maximal epigastric/abdominal pain relief after cryoablation
Description
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 Frame
3 Months
Title
Time to recurrence of epigastric/abdominal worst pain at or above baseline
Description
Measured worst pain score in the 12 week follow-up period as measured on a numeric 0-10 Brief Pain Inventory Scale
Time Frame
3 Months
Title
Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure
Description
Subjects will answer questions regarding their satisfaction.
Time Frame
3 Months
Title
Safety assessment
Description
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 Frame
30 Days post cryoablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David D Childs, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Research Foundation of State University New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19287104
Citation
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Results Reference
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PubMed Identifier
17659707
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.
Results Reference
background
PubMed Identifier
20362791
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.
Results Reference
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PubMed Identifier
1843146
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.
Results Reference
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PubMed Identifier
11935137
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.
Results Reference
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PubMed Identifier
14996778
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.
Results Reference
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PubMed Identifier
17100960
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.
Results Reference
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PubMed Identifier
15923103
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.
Results Reference
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Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer

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