drugset / Trial / NCT01525706
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
Phase 1
Terminated
1 enrolled
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
University of Western Ontario, Canada · collab
NaSingle-groupOpen-labelTreatment
Summary
Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection. Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.
Timeline
- Start
- 2012-09
- Primary completion
- 2016-11
- Completion
- 2016-11
Publications
- Results Oh HC, Seo DW, Song TJ, Moon SH, Park DH, Soo Lee S, Lee SK, Kim MH, Kim J. Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection treats patients with pancreatic cysts. Gastroenterology. 2011 Jan;140(1):172-9. doi: 10.1053/j.gastro.2010.10.001. Epub 2010 Oct 13.
- Results Oh HC, Seo DW, Lee TY, Kim JY, Lee SS, Lee SK, Kim MH. New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008 Apr;67(4):636-42. doi: 10.1016/j.gie.2007.09.038. Epub 2008 Feb 11.
- Results DeWitt J, DiMaio CJ, Brugge WR. Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. Gastrointest Endosc. 2010 Oct;72(4):862-6. doi: 10.1016/j.gie.2010.02.039.
- Results DeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 99 % | Other |
| Subject | Paclitaxel | Small molecule | 3 mg/ml | Other |