Organ function changes after open necrosectomy for infected necrotizing pancreatitis with sepsis
Official title: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy
Run by West China Hospital · NCT06380842 · Data updated 2026-11-12
This project will see if organ function improves or worsens after open necrosectomy in adults with infected necrotizing pancreatitis and sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, China) |
| Status | Recruiting |
| Started | June 15, 2024 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT06380842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with acute necrotizing pancreatitis who have confirmed or suspected infected pancreatic or peripancreatic necrosis, meet Sepsis-3 criteria, and are scheduled for open necrosectomy are ideal candidates.
✕Probably not a fit
Patients without infected necrotizing pancreatitis, those managed nonoperatively or with minimally invasive necrosectomy, patients undergoing repeat surgery at the same site, or those who refuse participation are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will track changes in organ dysfunction in adults with acute necrotizing pancreatitis and sepsis who undergo open necrosectomy. Investigators will collect demographic data, patient-reported pancreatic symptoms, and measure organ dysfunction using the Sequential Organ Failure Assessment (SOFA) score at preoperative, postoperative day 1, day 3, and day 7 or discharge. Participants will be contacted at 1, 3, and 6 months and 1 year after surgery to record symptom scores and survival. The aim is to characterize temporal patterns of organ dysfunction after open necrosectomy to help inform prognosis and postoperative management.
Why it matters
Potential benefit: If successful, the findings could help clinicians predict organ dysfunction trajectories after surgery and guide timing of supportive treatments and patient counseling.
How similar studies have gone: SOFA-based tracking of organ dysfunction has been used in sepsis and pancreatitis cohorts previously, but focused, prospective data specifically following open necrosectomy are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 18 years or older 2. Diagnosis of Acute pancreatitis according to the revised Atlanta classification, requires two of the following three criteria: (A) typical abdominal pain, (B) an increase in serum amylase or lipase levels higher than three times the upper limit of normality, and (C) signs of AP in imaging 3. Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy 4. Meet Sepsis-3 criteria Exclusion Criteria: 1. Patients refuse to participate 2. Patients undergo repeat surgery on the same site
Where it's running
-
West China Hospital, Sichuan University
Chengdu, China, China Recruiting
Study contacts
- Principal investigator: Fengming Luo, PhD — West China Hospital
- Study coordinator: Chunling Jiang, PhD
- Email: jiangchunling@scu.edu.cn
- Phone: 18980601096
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.