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

July 15, 2021 updated by: Boston Scientific Corporation

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New York
      • Stony Brook, New York, United States, 11794
        • The Research Foundation of State University New York
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain reduction following cryoablation of the celiac plexus
Time Frame: 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
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of abdominal pain relief
Time Frame: 3 Months
Measured from the cryoablation procedure to the return of the abdominal pain
3 Months
Cryoablation Procedure Information
Time Frame: 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
During the procedure on the procedure day (an expected average of 3 hours)
Hospital Duration
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Date and time of admission and discharge
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Difference in average pain scores
Time Frame: 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
3 Months
Percentage of subjects able to reduce analgesic medications
Time Frame: 3 Months
Measured from baseline to within 24 hours of the cryoablation procedure, 4, 8 and 12 weeks post cryoablation procedure
3 Months
Time to maximal epigastric/abdominal pain relief after cryoablation
Time Frame: 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
3 Months
Time to recurrence of epigastric/abdominal worst pain at or above baseline
Time Frame: 3 Months
Measured worst pain score in the 12 week follow-up period as measured on a numeric 0-10 Brief Pain Inventory Scale
3 Months
Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure
Time Frame: 3 Months
Subjects will answer questions regarding their satisfaction.
3 Months
Safety assessment
Time Frame: 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
30 Days post cryoablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: David D Childs, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUC10-PAN09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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