Benign Neoplasm of Pancreas Clinical Trial
Official title:
EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
Verified date | November 2016 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Mucinous cystic neoplasm defined by cyst fluid analysis [23, 28]: - CEA > 192ng/mL - Amylase < 800 IU/L - Cytology negative for malignant cells - No communication of cyst with pancreatic duct on 2 imaging studies (EUS, CT, MRCP, or ERCP) 2. Cyst size > 15mm but <50mm 3. 3 or fewer cyst compartments 4. Age =18 and = 85 Exclusion Criteria: 1. Inability to safely undergo EUS examination with standard conscious sedation 2. Inability for safe FNA needle insertion into the cyst (eg: intervening vessel) 3. Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia) 4. Coagulopathy (INR>1.5 or platelets<50) 5. Active pancreatitis or pancreatic infection 6. Active sepsis/bacteremia 7. Inability to provide informed consent 8. Pregnancy 9. Breastfeeding women |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Health Care | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | University of Western Ontario, Canada |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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.20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: Cyst Resolution | Proportion of patients without cysts at 6 months | 6 months | No |
Primary | Efficacy: Degree of Ablation | Degree of cyst epithelial ablation in those undergoing resection | 6 months | No |
Secondary | Safety | Safety of ethanol/paclitaxel ablation | 30 day | Yes |
Secondary | Efficacy: Change of tumor markers | Change of CEA level in those with persistent/recurrent cyst | 12 month | No |
Secondary | Efficacy: Cyst Resolution | Proportion of patients without cysts at 12 months | 12 month | No |
Secondary | Efficacy: Cyst Resolution | Proportion of patients without cysts at 18 months | 18 months | No |
Secondary | Efficacy: Cyst Resolution | Proportion of patients with no cysts at 24 months | 24 months | No |