ClinicalTrials.gg
RecruitingNCT05572788Updated Jan 31, 2024

Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts

An interventional study of EUS-guided fine needle aspiration of pancreatic cysts in Pancreatic Cyst and Pancreatitis, Acute, sponsored by Orlando Health, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Orlando Health, Inc. · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Pancreatic Cyst with a site in United States — 20 open to participants now, 23 under way, 1 of them phase 3. Pancreatic Cyst · United States.

Planned enrollment
3rd of 22
600 · median 53
Started
2022
with 1 other
No phase
13 of 54
5 open now
Primary completion
2025-07
later than 2 of 22 live
Registered
43rd of 54
by date
Lead sponsor
3 of 54
Orlando Health, Inc.

Among the 54 studies in Pancreatic Cyst with a site in United States, this one is the 3rd largest by planned enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2022, is one of 13 with no phase, reaches primary completion later than 2 of the 22 other live ones, and was the 43rd registered.

Pancreatic Cyst

97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.

Browse Pancreatic Cyst studies →

Open to participants now

20 of the 54 studies in Pancreatic Cyst with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 33 Pancreatic Cyst studies recruiting now, 25 (76%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Pancreatic Cyst
  • Pancreatitis, Acute
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA

Exclusion criteria

Exclusion Criteria:

  • Unable to obtain consent from the participant or the participant's legally authorized representative (LAR)
  • Intrauterine pregnancy
  • reaction to Aspirin or NSAIDs
  • Patients with known history of chronic pancreatitis
  • Patients with known renal failure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
600 participants (estimated)

Study 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)

    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

Interventions

  • ProcedureEUS-guided fine needle aspiration of pancreatic cysts

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

06

What researchers measure

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 .

    Time frame: 30 days

Secondary outcomes

  1. Rate of procedure-related adverse events

    Rate of adverse events resulting from EUS-FNA

    Time frame: 30 days

  2. Disease-related adverse events

    Any adverse event occurring as a result of underlying pancreatic cyst

    Time frame: 30 days

  3. Rate of mild, moderate and severe pancreatitis post-FNA

    Rate of mild, moderate and severe pancreatitis post-FNA

    Time frame: 30 days

  4. Length of hospitalization in any patient hospitalized with any adverse event

    Length of hospitalization in any patient hospitalized with any adverse event

    Time frame: 30 days

  5. Length of hospitalization in any patient hospitalized with acute pancreatitis

    Length of hospitalization in any patient hospitalized with acute pancreatitis

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Jul 2025, 34 months after the start.

Of 17 interventional studies with no phase under Pancreatic Cyst, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 34 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2022
First posted
Oct 10, 2022
StartActual
Sep 26, 2022
Primary completionEst.
Jul 2025
CompletionEst.
Dec 2025
Last update
Jan 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05572788
Lead sponsor
Orlando Health, Inc.
Responsible party
Sponsor
First posted
Oct 10, 2022
Start date
Sep 26, 2022
Primary completion
Jul 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 31, 2024

Study contacts

Barbara J Broome
Contact
barbara.broome@orlandohealth.com
321-841-7031
Ji Young Bang, MD MPH
principal investigator · Orlando Health, Digestive Health Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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