RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-09-26
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05572788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
  1. * Unable to obtain consent from the participant or the participant's legally authorized representative (LAR)
  2. * Intrauterine pregnancy
  3. * Hypersensitivity reaction to Aspirin or NSAIDs
  4. * Patients with known history of chronic pancreatitis
  5. * Patients with known renal failure

Contacts and Locations

Study Contact

Barbara J Broome
CONTACT
321-841-7031
barbara.broome@orlandohealth.com

Principal Investigator

Ji Young Bang, MD MPH
PRINCIPAL_INVESTIGATOR
Orlando Health, Digestive Health Institute

Study Locations (Sites)

Orlando Health
Orlando, Florida, 32806
United States

Collaborators and Investigators

Sponsor: Orlando Health, Inc.

  • Ji Young Bang, MD MPH, PRINCIPAL_INVESTIGATOR, Orlando Health, Digestive Health Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-26
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-09-26
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Pancreatic Cyst
  • Pancreatitis, Acute