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

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT01335945
Collaborator
(none)
14
3
1
41
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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
  • Procedure: Cryoablation
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

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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:
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Duration of abdominal pain relief [3 Months]

      Measured from the cryoablation procedure to the return of the abdominal pain

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    7. 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

    8. Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure [3 Months]

      Subjects will answer questions regarding their satisfaction.

    9. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT01335945
    Other Study ID Numbers:
    • CUC10-PAN09
    First Posted:
    Apr 15, 2011
    Last Update Posted:
    Jul 16, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Boston Scientific Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 16, 2021