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| ID | Type | Description | Link |
|---|---|---|---|
| 1894054 | Other Identifier | Orlando Health IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal Indomethacin | Active Comparator | Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories) |
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| Placebo | Placebo Comparator | Patients assigned to the Placebo group will receive two glycerin suppositories. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided fine needle aspiration of pancreatic cysts | Procedure | Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara J Broome | Contact | 321-841-7031 | barbara.broome@orlandohealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji Young Bang, MD MPH | Orlando Health, Digestive Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| 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 |