Organ function changes after open necrosectomy for infected necrotizing pancreatitis with sepsis
Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy
West China Hospital · NCT06380842
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West China Hospital (other) |
| Locations | 1 site (Chengdu, China) |
| Trial ID | NCT06380842 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chengdu, China
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Necrotizing Pancreatitis, Acute Necrotizing Pancreatitis, sepsis, organ dysfunction