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

NCT ID: NCT06380842

Last Updated: 2025-09-23

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

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-15

Study Completion Date

2026-12-30

Brief Summary

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

Detailed Description

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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). 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.

Conditions

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Necrotizing Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Necrotizing Pancreatitis patients' organ dysfunction progression

Intervention Type OTHER

Study the dynamic nature of organ dysfunction

Interventions

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Necrotizing Pancreatitis patients' organ dysfunction 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chunling Jiang

OTHER

Sponsor Role lead

Responsible Party

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Chunling Jiang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fengming Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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West China Hospital, Sichuan University

Chengdu, China, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunling Jiang, PhD

Role: CONTACT

18980601096

Qian Li, PhD

Role: CONTACT

18980601096

Facility Contacts

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Fengming Luo, PhD

Role: primary

02885423593

Other Identifiers

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2023HX1970

Identifier Type: -

Identifier Source: org_study_id

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