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Timing is everything: new trial challenges standard wait for pancreatitis procedure

NCT ID NCT07406698

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares early versus delayed endoscopic drainage in patients with infected necrotizing pancreatitis. About 104 adults with symptomatic, infected pancreatic fluid collections will be randomly assigned to receive the procedure within 4 weeks of disease onset or after the standard 4-week waiting period. The goal is to see if early intervention reduces major complications or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endoscopic drainage procedure
What this could lead to
If early intervention proves better, it could reduce complications and deaths from infected pancreatic necrosis and shorten hospital stays.
What could go wrong
This is a relatively small trial (104 participants) and early drainage may carry risks like bleeding or infection. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with symptomatic necrotic collection diagnosed on MRI or CT abdomen/pelvis, defined as fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall. 3. Documented or suspected infected necrotizing pancreatitis 1) Documented infected necrotizing pancreatitis, defined as: i. Positive culture obtained with percutaneous fine needle aspiration from the pancreatic necrotic collection (if intervention is undertaken ≤14 days of onset of acute pancreatitis) ii. OR gas in the necrotic collection on imaging at any time. 2) Suspected infected necrotizing pancreatitis, if \>14 days after onset of disease, defined as: i. Persistent organ failure in patients admitted to the ICU ii. OR presence of at least three of the following six clinical/laboratory parameters (SIRS criteria or elevated CRP or elevated procalcitonin) with no other infection focus. These clinical criteria are considered sufficiently reliable only after the initial 14 days of acute pancreatitis: 1. Temperature \>100.4 °F or \<96.8 °F 2. Heart rate \> 90 beats/min 3. Respiratory rate \>20 breaths/min or PaCO2 \< 32 mmHg 4. WBC count \>12,000/mm³, or \<4,000/mm³, or more than 10% immature band cells 5. CRP ≥ 30mg/L 6. Procalcitonin ≥ 1ng/mL 4. Endoscopic drainage of the necrotic collection is technically feasible as deemed by the treating physician. Exclusion Criteria: 1. Age \< 18 years 2. \> 26 days after the onset of acute pancreatitis 3. Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome). 4. Necrotic collection is not amenable for endoscopic intervention. 5. Pregnancy. 6. Unable to obtain informed consent from the patient or legally authorized representative.

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Conditions

The condition(s) this trial relates to.

acute necrotizing pancreatitis Pancreatitis, Acute Necrotizing

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Orlando Health Digestive Health Institute

    RECRUITING

    Orlando, Florida, 32806, United States

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