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PainPhase 1NCT01335945

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

A Phase 1 study testing Cryoablation in people with Pain and Pancreatic Cancer, run by Boston Scientific Corporation at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Pancreatic Cancer
What is being tested?
Cryoablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
Aug 2011to Jan 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University Hospitals

    Cleveland, Ohio, 44106

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • The Research Foundation of State University New York

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Cryoablation
Keywords
Cryoablation, Cryotherapy, Cryosurgery, Pancreas, Pancreatic Cancer, Celiac Plexus, Pain, Abdominal pain
Medical subject headings
Pain, Pancreatic Neoplasms, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryoablationProcedure or surgery

    Also called Cryotherapy, Visual-ICE cryoablation system, SeedNet cryoablation system, PresIce cryoablation system

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

Study groups in NCT01335945
Study groupRoleWhat they receive
CryoablationOtherFreezing of the celiac plexus
Receives: Procedure: Cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 Months

Secondary outcomes (9)

  1. Duration of abdominal pain relief

    Measured from the cryoablation procedure to the return of the abdominal pain

    Measured: 3 Months

  2. Cryoablation Procedure Information

    Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation

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

  3. Hospital Duration

    Date and time of admission and discharge

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

  4. 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

    Measured: 3 Months

  5. 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

    Measured: 3 Months

  6. 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

    Measured: 3 Months

  7. 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

    Measured: 3 Months

  8. Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure

    Subjects will answer questions regarding their satisfaction.

    Measured: 3 Months

  9. 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

    Measured: 30 Days post cryoablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Low enrollment \& subjects didn't survive to study end due to cancer progression.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335945
Sponsor's protocol ID
CUC10-PAN09
Status last verified
Jul 2021
First submitted
13 Apr 2011
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No

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.

    PubMed 19287104

  • 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.

    PubMed 17659707

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

    PubMed 20362791

  • 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.

    PubMed 1843146

  • 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.

    PubMed 11935137

  • 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.

    PubMed 14996778

  • 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.

    PubMed 17100960

  • 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.

    PubMed 15923103

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cryoablation in people with Pain and Pancreatic Cancer, run by Boston Scientific Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low enrollment \& subjects didn't survive to study end due to cancer progression.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal pain reduction following cryoablation of the celiac plexus (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01335945, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

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