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

Not Applicable

Recruiting

• Conditions: Pancreatic Cyst; Pancreatitis, Acute
• Interventions: Procedure: EUS-guided fine needle aspiration of pancreatic cysts

• Registration Number: NCT05572788
• Lead Sponsor: Orlando Health, Inc.

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.

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.

Study Timeline

• Study Start: 2022-09-26
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	EUS-guided fine needle aspiration of pancreatic cysts	Patients assigned to the Placebo group will receive two glycerin suppositories.
Rectal Indomethacin	EUS-guided fine needle aspiration of pancreatic cysts	Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories)

Primary Outcome Measures

Name	Time	Method
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts	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 .

Secondary Outcome Measures

Name	Time	Method
Disease-related adverse events	30 days	Any adverse event occurring as a result of underlying pancreatic cyst
Rate of procedure-related adverse events	30 days	Rate of adverse events resulting from EUS-FNA
Rate of mild, moderate and severe pancreatitis post-FNA	30 days	Rate of mild, moderate and severe pancreatitis post-FNA
Length of hospitalization in any patient hospitalized with any adverse event	30 days	Length of hospitalization in any patient hospitalized with any adverse event
Length of hospitalization in any patient hospitalized with acute pancreatitis	30 days	Length of hospitalization in any patient hospitalized with acute pancreatitis

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States