The aim of this randomized trial is to compare the rate of post-procedure pancreatitis in patients undergoing EUS-FNA of pancreatic cysts; patients will receive either a single dose of indomethacin or placebo administered rectally, during EUS-FNA.
Pancreatic cysts are pre-malignant lesions and are being increasingly diagnosed on cross-sectional imaging. Endoscopic ultrasound (EUS) is performed to further evaluate pancreatic cysts, and fine needle aspiration (FNA) is conducted to obtain a sample of the cystic fluid for analysis and examination for malignant cells. Acute pancreatitis is a complication of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, which can lead to significant morbidity and substantial health care costs. The aim of this randomized trial is to compare the rate of post-procedure pancreatitis in patients undergoing EUS-FNA of pancreatic cysts; patients will receive either a single dose of indomethacin or placebo administered rectally, during EUS-FNA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
600
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Orlando Health
Orlando, Florida, United States
RECRUITINGRate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
Post-procedure pancreatitis is defined as the development of new or increased abdominal pain consistent with acute pancreatitis, and elevated amylase or lipase at least three times the upper limit of normal .
Time frame: 30 days
Rate of procedure-related adverse events
Rate of adverse events resulting from EUS-FNA
Time frame: 30 days
Disease-related adverse events
Any adverse event occurring as a result of underlying pancreatic cyst
Time frame: 30 days
Rate of mild, moderate and severe pancreatitis post-FNA
Rate of mild, moderate and severe pancreatitis post-FNA
Time frame: 30 days
Length of hospitalization in any patient hospitalized with any adverse event
Length of hospitalization in any patient hospitalized with any adverse event
Time frame: 30 days
Length of hospitalization in any patient hospitalized with acute pancreatitis
Length of hospitalization in any patient hospitalized with acute pancreatitis
Time frame: 30 days
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