Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy

Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy

The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.

Study Overview

• Status: Recruiting
• Conditions: Necrotizing Pancreatitis
• Intervention / Treatment: Other: Necrotizing Pancreatitis patients' organ dysfunction progression

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Chunling Jiang, PhD; Phone Number: 18980601096; Email: jiangchunling@scu.edu.cn
• Study Contact Backup: Name: Qian Li, PhD; Phone Number: 18980601096; Email: jiangchunling@scu.edu.cn

Study Locations

• China
  • China
    • Chengdu, China, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Fengming Luo, PhD; Phone Number: 02885423593; Email: jiangchunling@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Acute necrotizing pancreatitis Patients with sepsis scheduled for open necrosectomy will be invited to participate in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy; Acute necrotizing pancreatitis patients with sepsis undergoing open necrosectomy will be measured SOFA scores at a special time point to characterize organ dysfunction experience profiles.	Other: Necrotizing Pancreatitis patients' organ dysfunction progression; Study the dynamic nature of organ dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure organ dysfunction change after open necrosectomy with respect to time	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	up to postoperative day 7, or at hospital discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of a composite of major complications	Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal)	up to postoperative day 28
Incidence of ICU mortality	Death occurred in ICU	through study completion, an average of 1year
Incidence of hospital mortality	Death occurred in hospital	through study completion, an average of 1 year
Incidence of 28-day mortality	Death occurred within 28-day after surgery	through study completion, an average of 1 year
Incidence of one year mortality	Death occurred within one year after surgery	through study completion, an average of 1 year
ICU length of hospital stay	Determined by the number of days from ICU admittance to discharge from ICU	through study completion, an average of 1 year
Length of hospital stay	Determined by the number of days from admittance to discharge	through study completion，an average of 1 year
The pancreatic symptoms score	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.	up to 1 year
The levels of inflammatory factor CRP	Peripheral blood CRP	preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
The levels of inflammatory cytokines IL-6	cytokines IL-6	preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
The levels of inflammatory procalcitonin	procalcitonin was measured at preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.	preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.

Collaborators and Investigators

• Sponsor: Chunling Jiang
• Investigators: Principal Investigator: Fengming Luo, PhD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: sepsis; organ dysfunction; Acute Necrotizing Pancreatitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Digestive System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatitis; Sepsis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 2023HX1970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No