Safety And Efficacy Of Cryoablation For Abdominal Pain Associated With Pancreatic Cancer

Study Overview

Safety and Efficacy of Cryoablation for 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.

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).

Pain
Pancreatic Cancer

PROCEDURE: Cryoablation

CUC10-PAN09

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-04-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-07-15
First Submitted that Met QC Criteria 2011-04-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-07-16
First Posted (ACTUAL) 2011-04-15	Results First Posted N/A	Last Verified 2021-07

Study Plan

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

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.

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.

Primary Outcome Measures	Measure Description	Time Frame
Abdominal pain reduction following cryoablation of the celiac plexus	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	Measure Description	Time Frame
Duration of abdominal pain relief	Measured from the cryoablation procedure to the return of the abdominal pain	3 Months
Cryoablation Procedure Information	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	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	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	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	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	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	Subjects will answer questions regarding their satisfaction.	3 Months
Safety assessment	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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: David D Childs, MD,

Publications

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

General Publications

Xiong LL, Hwang JH, Huang XB, Yao SS, He CJ, Ge XH, Ge HY, Wang XF. Early clinical experience using high intensity focused ultrasound for palliation of inoperable pancreatic cancer. JOP. 2009 Mar 9;10(2):123-9.
Michaels AJ, Draganov PV. Endoscopic ultrasonography guided celiac plexus neurolysis and celiac plexus block in the management of pain due to pancreatic cancer and chronic pancreatitis. World J Gastroenterol. 2007 Jul 14;13(26):3575-80. doi: 10.3748/wjg.v13.i26.3575.
Kruse EJ. Palliation in pancreatic cancer. Surg Clin North Am. 2010 Apr;90(2):355-64. doi: 10.1016/j.suc.2009.12.004.
Patiutko IuI, Barkanov AI, Kholikov TK, Lagoshnyi AT, Li LI, Samoilenko VM, Afrikian MN, Savel'eva EV. [The combined treatment of locally disseminated pancreatic cancer using cryosurgery]. Vopr Onkol. 1991;37(6):695-700. Russian.
Kovach SJ, Hendrickson RJ, Cappadona CR, Schmidt CM, Groen K, Koniaris LG, Sitzmann JV. Cryoablation of unresectable pancreatic cancer. Surgery. 2002 Apr;131(4):463-4. doi: 10.1067/msy.2002.121231.
Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9. doi: 10.1001/jama.291.9.1092.
Yan BM, Myers RP. Neurolytic celiac plexus block for pain control in unresectable pancreatic cancer. Am J Gastroenterol. 2007 Feb;102(2):430-8. doi: 10.1111/j.1572-0241.2006.00967.x. Epub 2006 Nov 13.
Stefaniak T, Basinski A, Vingerhoets A, Makarewicz W, Connor S, Kaska L, Stanek A, Kwiecinska B, Lachinski AJ, Sledzinski Z. A comparison of two invasive techniques in the management of intractable pain due to inoperable pancreatic cancer: neurolytic celiac plexus block and videothoracoscopic splanchnicectomy. Eur J Surg Oncol. 2005 Sep;31(7):768-73. doi: 10.1016/j.ejso.2005.03.012.

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