Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
Locations
United States
Florida
Orlando Health
RECRUITING
Orlando
Contact Information
Primary
Barbara J Broome
barbara.broome@orlandohealth.com
321-841-7031
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 600
Treatments
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)
Placebo_comparator: Placebo
Patients assigned to the Placebo group will receive two glycerin suppositories.
Related Therapeutic Areas
Sponsors
Leads: Orlando Health, Inc.