Necrotizing PancreatitisNCT06380842
Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy
An observational study of Necrotizing Pancreatitis, run by Chunling Jiang at 1 site in China.
Trial summary
The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after 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' organ dysfunction progression
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 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: Acute necrotizing pancreatitis Patients with sepsis scheduled for open necrosectomy will be invited to participate in this study.
Who may be able to join
- Patients 18 years or older
- 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
- Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy
- Meet Sepsis-3 criteria
Who cannot join
- Patients refuse to participate
- 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, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, China, 610041
Fengming Luo, PhD, 02885423593, jiangchunling@scu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Necrotizing Pancreatitis
- Being tested
- Necrotizing Pancreatitis patients' organ dysfunction progression
- Keywords
- Acute Necrotizing Pancreatitis, sepsis, organ dysfunction
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necrotizing Pancreatitis patients' organ dysfunction progressionOther
Study the dynamic nature of organ dysfunction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Necrotizing Pancreatitis patients' organ dysfunction 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 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
Measured: up to postoperative day 7, or at hospital discharge, whichever comes first
Secondary outcomes (11)
incidence of a composite of major complications
Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal)
Measured: up to postoperative day 28
Incidence of ICU mortality
Death occurred in ICU
Measured: through study completion, an average of 1year
Incidence of hospital mortality
Death occurred in hospital
Measured: through study completion, an average of 1 year
Incidence of 28-day mortality
Death occurred within 28-day after surgery
Measured: through study completion, an average of 1 year
Incidence of one year mortality
Death occurred within one year after surgery
Measured: 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
Measured: through study completion, an average of 1 year
Length of hospital stay
Determined by the number of days from admittance to discharge
Measured: 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.
Measured: up to 1 year
The levels of inflammatory factor CRP
Peripheral blood CRP
Measured: 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
Measured: 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.
Measured: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start15 Jun 2024
- 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.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunling Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunling Jiang, West China Hospital
- Investigators
- Fengming Luo, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380842
- Sponsor's protocol ID
- 2023HX1970
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2024
- Last updated
- 10 Jul 2026
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy
- ClinicalTrials.gov ID
- NCT06380842
- Acronym / sponsor ID
- 2023HX1970
- Conditions
- Necrotizing Pancreatitis
- Keywords
- Acute Necrotizing Pancreatitis, sepsis, organ dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chunling JiangUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Apr 2024 (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 study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy | – | Other: Necrotizing Pancreatitis patients' organ dysfunction progressionAcute necrotizing pancreatitis patients with sepsis undergoing open necrosectomy will be measured SOFA scores at a special time point to characterize organ dysfunction experience profiles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute necrotizing pancreatitis Patients with sepsis scheduled for open necrosectomy will be invited to participate in this study.
Key inclusion criteria (4 listed)
- Patients 18 years or older
- 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
- Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy
- Meet Sepsis-3 criteria
Key exclusion criteria (2 listed)
- Patients refuse to participate
- 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' organ dysfunction progressionStudy the dynamic nature of organ dysfunction | Other | Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy |
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 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
11 secondary outcomes
incidence of a composite of major complications
Time frame: up to postoperative day 28
Incidence of ICU mortality
Time frame: through study completion, an average of 1year
Incidence of hospital mortality
Time frame: through study completion, an average of 1 year
Incidence of 28-day mortality
Time frame: through study completion, an average of 1 year
Incidence of one year mortality
Time frame: through study completion, an average of 1 year
ICU length of hospital stay
Time frame: through study completion, an average of 1 year
Length of hospital stay
Time frame: through study completion，an average of 1 year
The pancreatic symptoms score
Time frame: up to 1 year
The levels of inflammatory factor CRP
Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
The levels of inflammatory cytokines IL-6
Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
The levels of inflammatory procalcitonin
Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
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 10 Jul 2026.
- 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.
Fengming Luo, PhD principal investigator
West China Hospital
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 Chunling Jiang 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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 (18980601096, 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 10 Jul 2026.