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

NCT ID: NCT05572788

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cyst Pancreatitis, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Rectal Indomethacin

Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories)

Group Type ACTIVE_COMPARATOR

EUS-guided fine needle aspiration of pancreatic cysts

Intervention Type PROCEDURE

Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial

Placebo

Patients assigned to the Placebo group will receive two glycerin suppositories.

Group Type PLACEBO_COMPARATOR

EUS-guided fine needle aspiration of pancreatic cysts

Intervention Type PROCEDURE

Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial

Interventions

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EUS-guided fine needle aspiration of pancreatic cysts

Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ji Young Bang, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Orlando Health, Digestive Health Institute

Locations

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Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Barbara J Broome

Role: CONTACT

321-841-7031

Facility Contacts

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Ji Young Bang, MD, MPH

Role: primary

321-841-2431

Barbara J Broome

Role: backup

321-841-7031

Other Identifiers

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1894054

Identifier Type: OTHER

Identifier Source: secondary_id

22.085.04

Identifier Type: -

Identifier Source: org_study_id

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