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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Pancreatic Cyst, Pancreatitis, Acute

NCT05572788

Orlando Health, Inc.

18 February 2024

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