Necrotizing Pancreatitis
Conditions
Keywords
Acute Necrotizing Pancreatitis, sepsis, organ dysfunction
Brief summary
The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.
Detailed description
Before surgery, study participants will be asked questions about age, gender, education level, etc. Study participants will also be questioned regarding pancreatic symptoms, as measured on the Patient-Reported Outcome Scale in Acute Pancreatitis (including pain, abdominal distention, eating, bowel movements, nausea and vomiting, thirst, and weakness). Organ dysfunction was defined according to the Sequential Organ Failure Assessment (SOFA) score. The SOFA score will be measured at preoperative (T1), postoperative day 1 (T2), postoperative day 3 (T3), postoperative day 7, or at hospital discharge, whichever comes first (T4). Participants who provide optional consent for biospecimen collection will have peripheral venous blood samples (5-10 mL) collected at predefined preoperative and postoperative time points. Samples will be processed and stored for biomarker analyses, including inflammatory marker measurement, metabolomic profiling, and other exploratory analyses related to the objectives of this study. Following discharge from the hospital, study participants will be contacted at 1 month, 3 months, 6 months, and 1 year after surgery, and asked to complete a survey about their pancreatic symptoms and survival status after surgery.
Interventions
OTHERNecrotizing Pancreatitis patients' organ dysfunction progression
Study the dynamic nature of organ dysfunction
Sponsors
Chunling Jiang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure organ dysfunction change after open necrosectomy with respect to time | up to postoperative day 7, or at hospital discharge, whichever comes first | Organ dysfunction will be measured using sequential organ failure assessment score scale. The scores range from 0 (normal) to 4(most abnormal) for each organ, with higher scores indicating worse health status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of a composite of major complications | up to postoperative day 28 | Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal) |
| Incidence of ICU mortality | through study completion, an average of 1year | Death occurred in ICU |
| Incidence of hospital mortality | through study completion, an average of 1 year | Death occurred in hospital |
| Incidence of 28-day mortality | through study completion, an average of 1 year | Death occurred within 28-day after surgery |
| Incidence of one year mortality | through study completion, an average of 1 year | Death occurred within one year after surgery |
| ICU length of hospital stay | through study completion, an average of 1 year | Determined by the number of days from ICU admittance to discharge from ICU |
| Length of hospital stay | through study completion，an average of 1 year | Determined by the number of days from admittance to discharge |
| The pancreatic symptoms score | up to 1 year | Pancreatic symptom scores will be measured at preoperative, postoperative day 1, day 2, day 3, day 7, or at hospital discharge, whichever comes first, at 1 month, 3 months, 6 months, and 1 year postoperatively. Both were measured using the Patient-Reported Outcome Scale, which ranges from 0 to 10 for each symptom; The overall range is from 0 to 70, with higher scores indicating higher symptom intensity. |
| The levels of inflammatory factor CRP | preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. | Peripheral blood CRP |
| The levels of inflammatory cytokines IL-6 | preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. | cytokines IL-6 |
| The levels of inflammatory procalcitonin | preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. | procalcitonin was measured at preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. |
Countries
China
Contacts
CONTACTChunling Jiang, PhD
CONTACTQian Li, PhD
PRINCIPAL_INVESTIGATORFengming Luo, PhD
West China Hospital
Outcome results
None listed