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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pain, Pancreatic Cancer

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Abdominal pain reduction following cryoablation of the celiac plexus

Outcome 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

Outcome Time Frame:

3 Months

Safety Issue:

No

Principal Investigator

David D Childs, MD

Investigator Role:

Principal Investigator

Authority:

United States: Institutional Review Board

Study ID:

CUC10-PAN09

NCT ID:

NCT01335945

Start Date:

August 2011

Completion Date:

September 2014

Related Keywords:

  • Pain
  • Pancreatic Cancer
  • Cryoablation
  • Cryotherapy
  • Cryosurgery
  • Pancreas
  • Pancreatic Cancer
  • Celiac Plexus
  • Pain
  • Abdominal pain
  • Abdominal Pain
  • Pancreatic Neoplasms

Name

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