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

This study is currently recruiting participants.
Verified October 2013 by Galil Medical
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT01335945
First received: April 13, 2011
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Pain
Pancreatic Cancer
Procedure: Cryoablation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Galil Medical:

Primary Outcome Measures:
  • Abdominal pain reduction following cryoablation of the celiac plexus [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Measured from the cryoablation procedure to the return of the abdominal pain

  • Cryoablation Procedure Information [ Time Frame: During the procedure on the procedure day (an expected average of 3 hours) ] [ Designated as safety issue: No ]
    Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation

  • Hospital Duration [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ] [ Designated as safety issue: No ]
    Date and time of admission and discharge

  • Difference in average pain scores [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Subjects will answer questions regarding their satisfaction.

  • Safety assessment [ Time Frame: 30 Days post cryoablation ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • IceEDGE 2.4 cryoablation needles
  • IceSphere cryoablation needles
  • IceSeed cryoablation needles

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335945

Contacts
Contact: Maria Plentl, MSN 651-287-5057 Maria.Plentl@galilmedical.com

Locations
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Barbara A Adam, RN,MSM,NP-C    313-576-9958    adamba@karmanos.org   
Principal Investigator: Peter J Littrup, MD         
Sub-Investigator: Hussein Aoun, MD         
Sub-Investigator: Barbara A Adams, RN,MSM,NP-C         
Sub-Investigator: Minsig Choi, MD         
Sub-Investigator: Walid Osta, MD         
Sub-Investigator: Carol Strong, RN         
United States, New York
The Research Foundation of State University New York Active, not recruiting
Stony Brook, New York, United States, 11794
United States, Ohio
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kelly Mortell, MD    216-207-7244    kelly.mortell@UHhospitals.org   
Principal Investigator: Dean Nakamoto, MD         
Sub-Investigator: Kelly Mortell, MD         
Sub-Investigator: Matthew Brocone, MD         
Sub-Investigator: Zachary Love, MD         
Sub-Investigator: John Haaga, MD         
Sub-Investigator: Jeffrey Hardacre, MD         
Sub-Investigator: Nami Azar, MD         
Sponsors and Collaborators
Galil Medical
Investigators
Principal Investigator: David D Childs, MD
  More Information

Publications:

Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT01335945     History of Changes
Other Study ID Numbers: CUC10-PAN09
Study First Received: April 13, 2011
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Galil Medical:
Cryoablation
Cryotherapy
Cryosurgery
Pancreas
Pancreatic Cancer
Celiac Plexus
Pain
Abdominal pain

Additional relevant MeSH terms:
Abdominal Pain
Pancreatic Neoplasms
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014