When to do endoscopic drainage for infected necrotizing pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses endoscopic ultrasound–guided transluminal drainage to manage symptomatic, infected necrotic pancreatic collections. Eligible adults have imaging-confirmed necrosis and documented or suspected infection and may receive earlier endoscopic intervention rather than waiting the traditional four-week walling-off period. Outcomes include infection control, organ failure, need for additional interventions or necrosectomy, complication rates, and length of hospital stay. The goal is to determine whether modern endoscopic approaches performed earlier can safely reduce morbidity and healthcare utilization compared with delayed management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Orlando Health Digestive Health Institute
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Ji Young Bang, MD MPH — Orlando Health
• Study coordinator: Ji Young Bang, MD MPH
• Email: jiyoung.bang@orlandohealth.com
• Phone: 321-842-2273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.