Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts

Conditions
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Pancreatic Cyst, Pancreatitis, Acute

Intervention / Treatment
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* Procedure: EUS-guided fine needle aspiration of pancreatic cysts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectal Indomethacin<br>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<br>* Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial<br>|
| Placebo Comparator: Placebo<br>Patients assigned to the Placebo group will receive two glycerin suppositories. | Procedure: EUS-guided fine needle aspiration of pancreatic cysts<br>* Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate 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 . | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of procedure-related adverse events | Rate of adverse events resulting from EUS-FNA | 30 days | 
| Disease-related adverse events | Any adverse event occurring as a result of underlying pancreatic cyst | 30 days | 
| Rate of mild, moderate and severe pancreatitis post-FNA | Rate of mild, moderate and severe pancreatitis post-FNA | 30 days | 
| Length of hospitalization in any patient hospitalized with any adverse event | Length of hospitalization in any patient hospitalized with any adverse event | 30 days | 
| Length of hospitalization in any patient hospitalized with acute pancreatitis | Length of hospitalization in any patient hospitalized with acute pancreatitis | 30 days |