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

Primary Purpose

Pancreatic Cyst, Pancreatitis, Acute

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EUS-guided fine needle aspiration of pancreatic cysts
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cyst

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orlando HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rectal Indomethacin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2022
Last Updated
October 4, 2022
Sponsor
Orlando Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05572788
Brief Title
Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
Official Title
Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orlando Health, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst, Pancreatitis, Acute

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectal Indomethacin
Arm Type
Active Comparator
Arm Description
Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients assigned to the Placebo group will receive two glycerin suppositories.
Intervention Type
Procedure
Intervention Name(s)
EUS-guided fine needle aspiration of pancreatic cysts
Intervention Description
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
Primary Outcome Measure Information:
Title
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
Description
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 .
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of procedure-related adverse events
Description
Rate of adverse events resulting from EUS-FNA
Time Frame
30 days
Title
Disease-related adverse events
Description
Any adverse event occurring as a result of underlying pancreatic cyst
Time Frame
30 days
Title
Rate of mild, moderate and severe pancreatitis post-FNA
Description
Rate of mild, moderate and severe pancreatitis post-FNA
Time Frame
30 days
Title
Length of hospitalization in any patient hospitalized with any adverse event
Description
Length of hospitalization in any patient hospitalized with any adverse event
Time Frame
30 days
Title
Length of hospitalization in any patient hospitalized with acute pancreatitis
Description
Length of hospitalization in any patient hospitalized with acute pancreatitis
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara J Broome
Phone
321-841-7031
Email
barbara.broome@orlandohealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Young Bang, MD MPH
Organizational Affiliation
Orlando Health, Digestive Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Young Bang, MD, MPH
Phone
321-841-2431
Email
jiyoung.bang@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Barbara J Broome
Phone
321-841-7031
Email
barbara.broome@orlandohealth.com

12. IPD Sharing Statement

Learn more about this trial

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

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