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2022-09-26
2025-07
2025-12
600
NCT05572788
Orlando Health, Inc.
Orlando Health, Inc.
INTERVENTIONAL
Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-10-04 | N/A | 2024-01-29 |
2022-10-04 | N/A | 2024-01-31 |
2022-10-10 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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) | PROCEDURE: EUS-guided fine needle aspiration of pancreatic cysts
|
| PLACEBO_COMPARATOR: Placebo Patients assigned to the Placebo group will receive two glycerin suppositories. | PROCEDURE: EUS-guided fine needle aspiration of pancreatic cysts
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts | Post-procedure pancreatitis is defined as the development of new or increased abdominal pain consistent with acute pancreatitis, and elevated amylase or lipase at least three times the upper limit of normal . | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of procedure-related adverse events | Rate of adverse events resulting from EUS-FNA | 30 days |
| Disease-related adverse events | Any adverse event occurring as a result of underlying pancreatic cyst | 30 days |
| Rate of mild, moderate and severe pancreatitis post-FNA | Rate of mild, moderate and severe pancreatitis post-FNA | 30 days |
| Length of hospitalization in any patient hospitalized with any adverse event | Length of hospitalization in any patient hospitalized with any adverse event | 30 days |
| Length of hospitalization in any patient hospitalized with acute pancreatitis | Length of hospitalization in any patient hospitalized with acute pancreatitis | 30 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Barbara J Broome Phone Number: 321-841-7031 Email: barbara.broome@orlandohealth.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
