Pancreatic CystNCT05572788
Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
A study testing EUS-guided fine needle aspiration of pancreatic cysts in people with Pancreatic Cyst and Pancreatitis, Acute, run by Orlando Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Pancreatitis, Acute
- What is being tested?
- EUS-guided fine needle aspiration of pancreatic cysts
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Ji Young Bang, MD, MPH, 321-841-2431, jiyoung.bang@orlandohealth.com
Barbara J Broome, 321-841-7031, barbara.broome@orlandohealth.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cyst, Pancreatitis, Acute
- Being tested
- EUS-guided fine needle aspiration of pancreatic cysts
- Medical subject headings
- Pancreatic Cyst, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided fine needle aspiration of pancreatic cystsProcedure or surgery
Patients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial
| Study group | Role | What they receive |
|---|---|---|
| Rectal Indomethacin | Active comparator | Patients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories) Receives: Procedure: EUS-guided fine needle aspiration of pancreatic cysts |
| Placebo | Placebo comparator | Patients assigned to the Placebo group will receive two glycerin suppositories. Receives: Procedure: EUS-guided fine needle aspiration of pancreatic cysts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 30 days
Secondary outcomes (5)
Rate of procedure-related adverse events
Rate of adverse events resulting from EUS-FNA
Measured: 30 days
Disease-related adverse events
Any adverse event occurring as a result of underlying pancreatic cyst
Measured: 30 days
Rate of mild, moderate and severe pancreatitis post-FNA
Rate of mild, moderate and severe pancreatitis post-FNA
Measured: 30 days
Length of hospitalization in any patient hospitalized with any adverse event
Length of hospitalization in any patient hospitalized with any adverse event
Measured: 30 days
Length of hospitalization in any patient hospitalized with acute pancreatitis
Length of hospitalization in any patient hospitalized with acute pancreatitis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start26 Sep 2022
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health, Digestive Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572788
- Sponsor's protocol ID
- 22.085.04
- Other IDs
- 1894054
- Status last verified
- Jan 2024
- First submitted
- 4 Oct 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
- ClinicalTrials.gov ID
- NCT05572788
- Acronym / sponsor ID
- 22.085.04
- Conditions
- Pancreatic Cyst, Pancreatitis, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal Indomethacin | Active comparator | Procedure: EUS-guided fine needle aspiration of pancreatic cystsPatients assigned to the Indomethacin group will receive100 mg of indomethacin administered per rectal route (two tablets of 50 mg indomethacin suppositories) |
| Placebo | Placebo comparator | Procedure: EUS-guided fine needle aspiration of pancreatic cystsPatients assigned to the Placebo group will receive two glycerin suppositories. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided fine needle aspiration of pancreatic cystsPatients with pancreatic cysts requiring fine needle aspiration will be enrolled in this randomized trial | Procedure or surgery | Placebo, Rectal Indomethacin |
Primary outcome
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
Time frame: 30 days
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 .
5 secondary outcomes
Rate of procedure-related adverse events
Time frame: 30 days
Disease-related adverse events
Time frame: 30 days
Rate of mild, moderate and severe pancreatitis post-FNA
Time frame: 30 days
Length of hospitalization in any patient hospitalized with any adverse event
Time frame: 30 days
Length of hospitalization in any patient hospitalized with acute pancreatitis
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Young Bang, MD MPH principal investigator
Orlando Health, Digestive Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided fine needle aspiration of pancreatic cysts in people with Pancreatic Cyst and Pancreatitis, Acute, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara J Broome (321-841-7031, barbara.broome@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.