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

Pancreatic Cyst Clinical Trial

Official title:

Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572788
• Other study ID #: 22.085.04
• Secondary ID: 1894054
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Orlando Health, Inc.
• Contact: Barbara J Broome
• Phone: 321-841-7031
• Email: barbara.broome[@]orlandohealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatitis
• Pancreatitis, Acute

Intervention

Procedure:
• EUS-guided fine needle aspiration of pancreatic cysts
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	30 days
Secondary	Rate of procedure-related adverse events	Rate of adverse events resulting from EUS-FNA	30 days
Secondary	Disease-related adverse events	Any adverse event occurring as a result of underlying pancreatic cyst	30 days
Secondary	Rate of mild, moderate and severe pancreatitis post-FNA	Rate of mild, moderate and severe pancreatitis post-FNA	30 days
Secondary	Length of hospitalization in any patient hospitalized with any adverse event	Length of hospitalization in any patient hospitalized with any adverse event	30 days
Secondary	Length of hospitalization in any patient hospitalized with acute pancreatitis	Length of hospitalization in any patient hospitalized with acute pancreatitis	30 days