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

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

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 Overview

• Status: Recruiting
• Conditions: Pancreatic Cyst; Pancreatitis, Acute
• Intervention / Treatment: Procedure: EUS-guided fine needle aspiration of pancreatic cysts

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 Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara J Broome; Phone Number: 321-841-7031; Email: barbara.broome@orlandohealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health
      • Contact: Ji Young Bang, MD, MPH; Phone Number: 321-841-2431; Email: jiyoung.bang@orlandohealth.com
      • Contact: Barbara J Broome; Phone Number: 321-841-7031; Email: barbara.broome@orlandohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Placebo Comparator: Placebo; Patients assigned to the Placebo group will receive two glycerin suppositories.	Procedure: EUS-guided fine needle aspiration of pancreatic cysts; Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Investigators: Principal Investigator: Ji Young Bang, MD MPH, Orlando Health, Digestive Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Pancreatitis; Pancreatic Cyst; Cysts
• Other Study ID Numbers: 22.085.04; 1894054 (Other Identifier: Orlando Health IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes