Necrotizing PancreatitisNCT07201246
Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy
An observational study of Necrotizing Pancreatitis, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Pancreatitis
- What is being tested?
- Necrotizing Pancreatitis patients' organdysfunction progression
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort included patients with acute necrotizing pancreatitis complicated by sepsis who underwent open necrosectomy
Who may be able to join
- 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
Who cannot join
- Patients undergo repeat surgery on the same site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Sichuan University
Chengdu, China, 610041
Fengming Luo, PhD, 02885423593, jiangchunling@scu.edu.cn
About this study
Official title: Retrospective Analysis of Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy：A Retrospective Cohort Study
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.
Read the detailed description
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
- Necrotizing Pancreatitis
- Being tested
- Necrotizing Pancreatitis patients' organdysfunction progression
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necrotizing Pancreatitis patients' organdysfunction progressionOther
Study the dynamic nature of organ dysfunction
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Necrotizing Pancreatitis patients' organdysfunction progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to postoperative day 7, or at hospital discharge, whichever comes first
Secondary outcomes (6)
Incidence of ICU mortality
Measured: an average of 1year
Incidence of hospital mortality
Measured: an average of 1 year
Incidence of 28-day mortality
Measured: an average of 1 year
Incidence of one year mortality
Measured: an average of 1 year
ICU length of hospital stay
Measured: an average of 1 year
Length of hospital stay
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start5 Oct 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing PancreatitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201246
- Sponsor's protocol ID
- 2024-162
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy：A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07201246
- Acronym / sponsor ID
- 2024-162
- Conditions
- Necrotizing Pancreatitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatitis with sepsis patients' organdysfunction progression after opennecrosectomy | – | Other: Necrotizing Pancreatitis patients' organdysfunction progressionSOFA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort included patients with acute necrotizing pancreatitis complicated by sepsis who underwent open necrosectomy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients undergo repeat surgery on the same site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Necrotizing Pancreatitis patients' organdysfunction progressionStudy the dynamic nature of organ dysfunction | Other | Pancreatitis with sepsis patients' organdysfunction progression after opennecrosectomy |
Primary outcome
Measure organ dysfunction change after open necrosectomy with respect to time
Time frame: up to postoperative day 7, or at hospital discharge, whichever comes first
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.
6 secondary outcomes
Incidence of ICU mortality
Time frame: an average of 1year
Incidence of hospital mortality
Time frame: an average of 1 year
Incidence of 28-day mortality
Time frame: an average of 1 year
Incidence of one year mortality
Time frame: an average of 1 year
ICU length of hospital stay
Time frame: an average of 1 year
Length of hospital stay
Time frame: an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Pancreatitis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunling Jiang, PhD (02885423593, jiangchunling@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure organ dysfunction change after open necrosectomy with respect to time (time frame: up to postoperative day 7, or at hospital discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.