Recruiting

Indomethacin

Sponsor:

Orlando Health, Inc.

Code:

NCT05572788

Conditions

Pancreatic Cyst

Pancreatitis, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS-guided fine needle aspiration of pancreatic cysts

Study Details

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.

Conditions

Pancreatic Cyst

Pancreatitis, Acute

Study ID

NCT05572788

Start date

Sep 26, 2022

Status verified date

Jan, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

EUS-guided fine needle aspiration of pancreatic cysts

Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial

Primary outcome measure

  • Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Barbara J Broome

321-841-7031barbara.broome@orlandohealth.com

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Ji Young Bang, MD, MPH

321-841-2431jiyoung.bang@orlandohealth.com

Barbara J Broome

321-841-7031barbara.broome@orlandohealth.com

More Information

Sponsor

Orlando Health, Inc.

Last update posted

Jan 31, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando Health, Inc. on 2024-01-31.