Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Rectal Indomethacin Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories) |
Procedure: EUS-guided fine needle aspiration of pancreatic cysts
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
|
| Placebo Comparator: Placebo Patients assigned to the Placebo group will receive two glycerin suppositories. |
Procedure: EUS-guided fine needle aspiration of pancreatic cysts
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
|
Outcome Measures
Primary Outcome Measures
- Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts [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 Outcome Measures
- Rate of procedure-related adverse events [30 days]
Rate of adverse events resulting from EUS-FNA
- Disease-related adverse events [30 days]
Any adverse event occurring as a result of underlying pancreatic cyst
- Rate of mild, moderate and severe pancreatitis post-FNA [30 days]
Rate of mild, moderate and severe pancreatitis post-FNA
- Length of hospitalization in any patient hospitalized with any adverse event [30 days]
Length of hospitalization in any patient hospitalized with any adverse event
- Length of hospitalization in any patient hospitalized with acute pancreatitis [30 days]
Length of hospitalization in any patient hospitalized with acute pancreatitis
Eligibility Criteria
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
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Patients with known renal failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Health | Orlando | Florida | United States | 32806 |
Sponsors and Collaborators
- Orlando Health, Inc.
Investigators
- Principal Investigator: Ji Young Bang, MD MPH, Orlando Health, Digestive Health Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22.085.04
- 1894054