Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age ≥ 18 years
- Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
Exclusion criteria
- Unable to obtain consent from the participant or the participant's legally authorized representative (LAR)
- Intrauterine pregnancy
- Hypersensitivity reaction to Aspirin or NSAIDs
- Patients with known history of chronic pancreatitis
- Patients with known renal failure
Trial design
Primary purpose
Allocation
Interventional model
Masking
600 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Barbara J Broome
Data sourced from clinicaltrials.gov
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