Using rectal indomethacin to prevent pancreatitis during pancreatic cyst procedures
Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
This study tests if giving rectal indomethacin can help prevent pancreatitis in patients undergoing a procedure to examine pancreatic cysts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orlando Health, Inc. Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05572788 on ClinicalTrials.gov |
What this trial studies
This randomized trial aims to evaluate the effectiveness of rectal indomethacin in reducing the incidence of post-procedure pancreatitis in patients undergoing endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts. Participants will be randomly assigned to receive either a single dose of indomethacin or a placebo during the EUS-FNA procedure. The study focuses on patients with suspected or confirmed pancreatic cysts, which are increasingly diagnosed and can lead to complications such as acute pancreatitis. By comparing the outcomes between the two groups, the trial seeks to determine if indomethacin can significantly lower the risk of pancreatitis following the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older with suspected or confirmed pancreatic cysts requiring EUS-FNA.
Not a fit: Patients who may not benefit from this study include those with a history of chronic pancreatitis, renal failure, or hypersensitivity to NSAIDs.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of acute pancreatitis in patients undergoing EUS-FNA, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: While the specific use of rectal indomethacin in this context may be novel, similar studies have explored the use of NSAIDs to prevent pancreatitis with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orlando, Florida
- Orlando Health — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ji Young Bang, MD MPH — Orlando Health, Digestive Health Institute
- Study coordinator: Barbara J Broome
- Email: barbara.broome@orlandohealth.com
- Phone: 321-841-7031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.