NCT01335945

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_1 pain

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

3.4 years

First QC Date

April 13, 2011

Last Update Submit

July 15, 2021

Conditions

PainPancreatic Cancer

Keywords

CryoablationCryotherapyCryosurgeryPancreasPancreatic CancerCeliac PlexusPainAbdominal pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Duration of abdominal pain relief

    3 Months

  • Cryoablation Procedure Information

    During the procedure on the procedure day (an expected average of 3 hours)

  • Hospital Duration

    Participants will be followed for the duration of hospital stay, an expected average of 1 day

  • Difference in average pain scores

    3 Months

  • Percentage of subjects able to reduce analgesic medications

    3 Months

  • +4 more secondary outcomes

Study Arms (1)

Cryoablation

OTHER

Freezing of the celiac plexus

Procedure: Cryoablation

Interventions

CryoablationPROCEDURE

All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.

Also known as: 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
Cryoablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

The Research Foundation of State University New York

Stony Brook, New York, 11794, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (8)

  • 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.

    PMID: 19287104BACKGROUND

  • 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.

    PMID: 17659707BACKGROUND

  • Kruse EJ. Palliation in pancreatic cancer. Surg Clin North Am. 2010 Apr;90(2):355-64. doi: 10.1016/j.suc.2009.12.004.

    PMID: 20362791BACKGROUND

  • 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.

    PMID: 1843146BACKGROUND

  • 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.

    PMID: 11935137BACKGROUND

  • 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.

    PMID: 14996778BACKGROUND

  • 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.

    PMID: 17100960BACKGROUND

  • 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.

    PMID: 15923103BACKGROUND

MeSH Terms

Conditions

PainPancreatic NeoplasmsAbdominal Pain

Interventions

CryosurgeryCryotherapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeTherapeutics

Study Officials

  • David D Childs, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 15, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

US(3)