Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
NCT ID: NCT05572788
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2022-09-26
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Rectal Indomethacin
Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories)
EUS-guided fine needle aspiration of pancreatic cysts
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Placebo
Patients assigned to the Placebo group will receive two glycerin suppositories.
EUS-guided fine needle aspiration of pancreatic cysts
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Interventions
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EUS-guided fine needle aspiration of pancreatic cysts
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Eligibility Criteria
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Inclusion Criteria
* Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
Exclusion Criteria
* Intrauterine pregnancy
* Hypersensitivity reaction to Aspirin or NSAIDs
* Patients with known history of chronic pancreatitis
* Patients with known renal failure
18 Years
ALL
No
Sponsors
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Orlando Health, Inc.
OTHER
Responsible Party
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Principal Investigators
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Ji Young Bang, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Orlando Health, Digestive Health Institute
Locations
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Orlando Health
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1894054
Identifier Type: OTHER
Identifier Source: secondary_id
22.085.04
Identifier Type: -
Identifier Source: org_study_id
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