Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
2 other identifiers
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2022
CompletedFirst Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 31, 2024
January 1, 2024
2.8 years
October 4, 2022
January 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Rate of procedure-related adverse events
30 days
Disease-related adverse events
30 days
Rate of mild, moderate and severe pancreatitis post-FNA
30 days
Length of hospitalization in any patient hospitalized with any adverse event
30 days
Length of hospitalization in any patient hospitalized with acute pancreatitis
30 days
Study Arms (2)
Rectal Indomethacin
ACTIVE COMPARATORPatients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories)
Placebo
PLACEBO COMPARATORPatients assigned to the Placebo group will receive two glycerin suppositories.
Interventions
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orlando Health
Orlando, Florida, 32806, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Young Bang, MD MPH
Orlando Health, Digestive Health Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 10, 2022
Study Start
September 26, 2022
Primary Completion
July 1, 2025
Study Completion
December 1, 2025
Last Updated
January 31, 2024
Record last verified: 2024-01