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| Name | Class |
|---|---|
| University of Western Ontario, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethanol and Paclitaxel Injection | Experimental | All patients will receive at least one treatment with alcohol and paclitaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol and Paclitaxel Injection | Drug | Endoscopic ultrasound will be used to locate and assess the pancreatic cyst. The fluid contents will be aspirated using a fine needle and sent for tumor marker analysis and cytology. With the needle maintained in the same position, 99% ethanol will be injected into the cyst. After 3-5 minutes of lavage, the entire volume of fluid will be removed from the cyst. The same volume of paclitaxel minus 1 mL [3mg/ml diluted in normal saline from original concentration of 6mg/mL] will be injected and left in the cyst. The needle is then retracted and the procedure completed. Patients will receive oral prophylactic antibiotics for 5 days after the procedure. Clinical follow up with MRI imaging with be done at 6, 12, 18, and 24 months. For those with a persistent cyst at 12 months, a repeat EUS FNI procedure will be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Cyst Resolution | Proportion of patients without cysts at 6 months | 6 months |
| Efficacy: Degree of Ablation | Degree of cyst epithelial ablation in those undergoing resection | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety of ethanol/paclitaxel ablation | 30 day |
| Efficacy: Change of tumor markers | Change of CEA level in those with persistent/recurrent cyst |
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Inclusion Criteria:
Mucinous cystic neoplasm defined by cyst fluid analysis [23, 28]:
Cyst size > 15mm but <50mm
3 or fewer cyst compartments
Age ≥18 and ≤ 85
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Yan, MD, FRCPC | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Health Care | London | Ontario | N6A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20950614 | Result | 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. | |
| 18262182 | Result | 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. |
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| 12 month |
| Efficacy: Cyst Resolution | Proportion of patients without cysts at 12 months | 12 month |
| Efficacy: Cyst Resolution | Proportion of patients without cysts at 18 months | 18 months |
| Efficacy: Cyst Resolution | Proportion of patients with no cysts at 24 months | 24 months |
| 20883866 | Result | 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. |
| 19577745 | Result | 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. |
| ID | Term |
|---|---|
| D000431 | Ethanol |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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