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Trial Title:
Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
NCT ID:
NCT05572788
Condition:
Pancreatic Cyst
Pancreatitis, Acute
Conditions: Official terms:
Cysts
Pancreatic Cyst
Pancreatitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
EUS-guided fine needle aspiration of pancreatic cysts
Description:
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this
randomized trial
Arm group label:
Placebo
Arm group label:
Rectal Indomethacin
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.
Detailed description:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ji Young Bang, MD, MPH
Phone:
321-841-2431
Email:
jiyoung.bang@orlandohealth.com
Contact backup:
Last name:
Barbara J Broome
Phone:
321-841-7031
Email:
barbara.broome@orlandohealth.com
Start date:
September 26, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Orlando Health, Inc.
Agency class:
Other
Source:
Orlando Health, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05572788
