Status:
TERMINATED
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
University of Western Ontario, Canada
Conditions:
Mucinous Cystic Tumor With Moderate Dysplasia
Mucinous Cystadenoma of Pancreas
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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 rem...
Eligibility Criteria
Inclusion
- 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)
- Cyst size \> 15mm but \<50mm
- 3 or fewer cyst compartments
- Age ≥18 and ≤ 85
Exclusion
- Inability to safely undergo EUS examination with standard conscious sedation
- Inability for safe FNA needle insertion into the cyst (eg: intervening vessel)
- Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia)
- Coagulopathy (INR\>1.5 or platelets\<50)
- Active pancreatitis or pancreatic infection
- Active sepsis/bacteremia
- Inability to provide informed consent
- Pregnancy
- Breastfeeding women
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01525706
Start Date
September 1 2012
End Date
November 1 2016
Last Update
November 2 2016
Active Locations (1)
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1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2