Timing is everything: new trial challenges standard wait for pancreatitis procedure
NCT ID NCT07406698
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
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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
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Orlando Health Digestive Health Institute
RECRUITINGOrlando, Florida, 32806, United States
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