Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy

NCT07201246 | Not Yet Recruiting

• 1 other identifier: 2024-162
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this retrospective study was to characterize the changes in organ dysfunction among patients with acute necrotizing pancreatitis complicated by sepsis who underwent open necrosectomy.

Conditions

Necrotizing Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Measure organ dysfunction change after open necrosectomy with respect to time

  Organ dysfunction was assessed retrospectively using the Sequential Organ Failure Assessment (SOFA) score, which ranges from 0 (normal) to 4 (most abnormal) for each organ, with higher scores indicating more severe dysfunction.

  up to postoperative day 7, or at hospital discharge, whichever comes first

Secondary Outcomes (6)

• Incidence of ICU mortality

  an average of 1year

• Incidence of hospital mortality

  an average of 1 year

• Incidence of 28-day mortality

  an average of 1 year

• Incidence of one year mortality

  an average of 1 year

• ICU length of hospital stay

  an average of 1 year

Study Arms (1)

Pancreatitis with sepsis patients' organdysfunction progression after opennecrosectomy

SOFA scores at predefined time points were retrospectively extracted from the institutional database in acute necrotizing pancreatitis patients with sepsis who underwent open necrosectomy to characterize organ dysfunction trajectories

Other: Necrotizing Pancreatitis patients' organdysfunction progression

Interventions

Necrotizing Pancreatitis patients' organdysfunction progression OTHER

Study the dynamic nature of organ dysfunction

Pancreatitis with sepsis patients' organdysfunction progression after opennecrosectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This retrospective cohort included patients with acute necrotizing pancreatitis complicated by sepsis who underwent open necrosectomy

You may qualify if:

• Patients 18 years or older
• Diagnosis of Acute pancreatitis according to the revised Atlanta classification, requires two of thefollowing three criteria: (A) typical abdominal pain, (B) an increase in serum amylase or lipaselevels higher than three times the upper limit of normality, and (C) signs of AP in imaging3)Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis werescheduled for open necrosectomy
• Meet Sepsis-3 criteria

You may not qualify if:

• Patients undergo repeat surgery on the same site

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, China, 610041, China

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Chunling Jiang, PhD

CONTACT

02885423593; jiangchunling@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 1, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)