Clinical trial · Interventional
Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer
NCT01335945CI-TRIAL-00052739terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment \& subjects didn't survive to study end due to cancer progression.
Summary
Brief summary (as posted)
CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cryoablation
- description
- Freezing of the celiac plexus
- interventionNames
- Procedure: Cryoablation
Primary outcomes (1)
- measure
- Abdominal pain reduction following cryoablation of the celiac plexus
- timeFrame
- 3 Months
- 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
Secondary outcomes (9)
- measure
- Duration of abdominal pain relief
- timeFrame
- 3 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDXiong 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 19287104
- BACKGROUNDMichaels 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 17659707
- BACKGROUNDKruse EJ. Palliation in pancreatic cancer. Surg Clin North Am. 2010 Apr;90(2):355-64. doi: 10.1016/j.suc.2009.12.004. PMID 20362791
- BACKGROUNDPatiutko 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 1843146
- BACKGROUNDKovach 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 11935137
- BACKGROUNDWong 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 14996778
- BACKGROUNDYan 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 17100960