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NCT05572788
Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
NA trial testing EUS-guided fine needle aspiration of pancreatic cysts in Pancreatic Cyst in 600 participants. Status unknown.
1 July 2025
Quick facts
| Lead sponsor | Orlando Health, Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 600 |
| Start date | 26 September 2022 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- EUS-guided fine needle aspiration of pancreatic cysts
Conditions studied
- Pancreatic Cyst — all drugs for Pancreatic Cyst →
- Pancreatitis, Acute — all drugs for Pancreatitis, Acute →
Sponsor
Orlando Health, Inc. — full company profile →
Who can join
18 and older, any sex, with Pancreatic Cyst or Pancreatitis, Acute. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
Time frame: 30 days
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 .
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05572788
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pancreatic Cyst
Currently open trials in the same condition.
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- NCT05873699 — Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Under · Phase 1 · recruiting
- NCT05334836 — Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features · NA · recruiting
- NCT06706700 — Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with IPMN o · recruiting
Other Orlando Health, Inc. trials
Trials by the same sponsor.
- NCT07406698 — Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis · NA · recruiting
- NCT06178315 — EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis · NA · recruiting
- NCT06576869 — Timing of Tourniquet Release · NA · completed
- NCT04231279 — Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency · Phase 3 · terminated
- NCT05043415 — Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05572788 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Orlando Health, Inc.
- Last refreshed: 29 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05572788.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing