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

NCT ID: NCT07201246

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-05

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Baseline demographic and clinical characteristics (including age, gender, and education level) were collected from medical records. Organ dysfunction was defined according to the Sequential Organ Failure Assessment (SOFA) score. SOFA scores were extracted at predefined time points: preoperative (T1), postoperative day 1 (T2), postoperative day 3 (T3), and either postoperative day 7 or hospital discharge, whichever occurred first (T4). Postoperative survival status up to 1 year was obtained from the institutional database.

Conditions

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Necrotizing Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Necrotizing Pancreatitis patients' organdysfunction progression

Intervention Type OTHER

Study the dynamic nature of organ dysfunction

Interventions

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Necrotizing Pancreatitis patients' organdysfunction progression

Study the dynamic nature of organ dysfunction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients 18 years or older
2. 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
3. Meet Sepsis-3 criteria

Exclusion Criteria

Patients undergo repeat surgery on the same site
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunling Jiang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital, Sichuan University

Chengdu, China, China

Site Status

Countries

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China

Central Contacts

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Chunling Jiang, PhD

Role: CONTACT

02885423593

Facility Contacts

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Fengming Luo, PhD

Role: primary

02885423593

Other Identifiers

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2024-162

Identifier Type: -

Identifier Source: org_study_id

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