Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT01335945|
Recruitment Status : Terminated (Low enrollment & subjects didn't survive to study end due to cancer progression.)
First Posted : April 15, 2011
Last Update Posted : May 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain Pancreatic Cancer||Procedure: Cryoablation||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||14 participants|
|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 :||August 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Freezing of the celiac plexus
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
- 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
- Duration of abdominal pain relief [ Time Frame: 3 Months ]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) ]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 ]Date and time of admission and discharge
- 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
- 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
- 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
- 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
- Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure [ Time Frame: 3 Months ]Subjects will answer questions regarding their satisfaction.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335945
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|The Research Foundation of State University New York|
|Stony Brook, New York, United States, 11794|
|United States, Ohio|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||David D Childs, MD|