Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cyst
- Sponsor
- Orlando Health, Inc.
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
Time Frame: 30 days
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 .
Secondary Outcomes
- Rate of procedure-related adverse events(30 days)
- Disease-related adverse events(30 days)
- Rate of mild, moderate and severe pancreatitis post-FNA(30 days)
- Length of hospitalization in any patient hospitalized with any adverse event(30 days)
- Length of hospitalization in any patient hospitalized with acute pancreatitis(30 days)