Status:
UNKNOWN
Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
Lead Sponsor:
Samsung Medical Center
Conditions:
Pancreatic Mucinous-Cystic Neoplasm
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant. The diagnosing s...
Eligibility Criteria
Inclusion
- Patients age 18 and older of any gender, ethnicity and race
- Voluntary enrollment and ability to give written informed consent
- Capable of safely undergoing endoscopy with deep sedation or general anesthesia
- Indeterminate cystic lesion which was diagnosed in cross-sectional image (CT and MRI)
- Pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules within a cyst) and 2\~4 cm in diameter
Exclusion
- Pancreatic cystic lesions which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute pancreatitis or parenchymal changes)
- Pancreatic cystic lesions having communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde cholangiopancreatography and magnetic resonance cholangiopancreatography
- Pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic invasion
- Patients with a bleeding tendency (prothrombin time \> 1.5 international normalized ratio \[INR\] or platelet count \< 50,000/μL).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02213419
Start Date
October 1 2014
End Date
August 1 2016
Last Update
February 12 2015
Active Locations (1)
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1
Samsung Medical Cencer
Seoul, South Korea, 135-710