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Indomethacin for Preventing Acute Pancreatitis After EUS-FNA

N/A
Recruiting
Led By Ji Young Bang, MD MPH
Research Sponsored by Orlando Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days

Summary

This trial tests if a single dose of medication can reduce the risk of pancreatitis after a medical procedure.

Who is the study for?
This trial is for adults over 18 with suspected or confirmed pancreatic cysts needing EUS-FNA. It's not for those with chronic pancreatitis, pregnant women, people allergic to Aspirin/NSAIDs, or those with renal failure.
What is being tested?
The study tests if a single dose of indomethacin given rectally can prevent acute pancreatitis after EUS-FNA of pancreatic cysts compared to a placebo.
What are the potential side effects?
Indomethacin may cause side effects like headaches, dizziness, gastrointestinal issues (like nausea and vomiting), and in rare cases serious heart or kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pancreatic Cyst
Secondary study objectives
Disease-related adverse events
Pancreatitis
Length of hospitalization in any patient hospitalized with any adverse event
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Rectal IndomethacinActive Control1 Intervention
Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories)
Group II: PlaceboPlacebo Group1 Intervention
Patients assigned to the Placebo group will receive two glycerin suppositories.

Find a Location

Who is running the clinical trial?

Orlando Health, Inc.Lead Sponsor
31 Previous Clinical Trials
14,517 Total Patients Enrolled
2 Trials studying Pancreatic Cyst
1,640 Patients Enrolled for Pancreatic Cyst
Ji Young Bang, MD MPHPrincipal InvestigatorOrlando Health, Digestive Health Institute
5 Previous Clinical Trials
1,313 Total Patients Enrolled
1 Trials studying Pancreatic Cyst
140 Patients Enrolled for Pancreatic Cyst

Media Library

Rectal Indomethacin Clinical Trial Eligibility Overview. Trial Name: NCT05572788 — N/A
Pancreatic Cyst Research Study Groups: Rectal Indomethacin, Placebo
Pancreatic Cyst Clinical Trial 2023: Rectal Indomethacin Highlights & Side Effects. Trial Name: NCT05572788 — N/A
Rectal Indomethacin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05572788 — N/A
~127 spots leftby Jul 2025
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