Acute Necrotizing PancreatitisPROMOTENCT07308600
Integrating Plasma Metagenomics and Host Response for Accurate Diagnosis of Infected Pancreatic Necrosis in a Prospective Multicenter Cohort of Acute Necrotizing Pancreatitis
An observational study of Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis, run by Xiangya Hospital of Central South University.
Trial summary
This study is being done to find a faster and more accurate way to tell whether the necrosis in patients with acute necrotizing pancreatitis (ANP) has become infected. In the absence of microbiological confirmation, clinicians often have to initiate empirical antibiotic therapy for suspected pancreatic infection-a… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Necrotizing Pancreatitis, Infected Pancreatic Necrosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute necrotizing pancreatitis from Xiangya Hospital Central South University, Affiliated Hospital of Guizhou Medical University, Liuzhou People's Hospital, Hunan University of Medicine General Hospital.
Who may be able to join
- Confirmed acute necrotizing pancreatitis (Revised Atlanta 2012) within 48 h of symptom onset
- Age ≥14 years
- Written informed consent
Who cannot join
- Invasive interventions including percutaneous catheter drainage (PCD) and surgical necrosectomy have already been performed prior to admission.
- Confirmed infection outside of pancreas, including pulmonary infection, urinary tract infection.
- Pregnancy .
- Acute recurrent pancreatitis
About this study
This study is being done to find a faster and more accurate way to tell whether the necrosis in patients with acute necrotizing pancreatitis (ANP) has become infected. In the absence of microbiological confirmation, clinicians often have to initiate empirical antibiotic therapy for suspected pancreatic infection-a practice supported by current guidelines but one that may contribute to antimicrobial resistance. In this study, the investigators will combine metagenomic next-generation sequencing (mNGS) which could improve the accuracy of infected pancreatic necrosis (IPN) diagnosis and host transcriptional response analysis which could discriminate infectious and noninfectious inflammatory syndromes. In a prospective, multicentre, cohort study, 200 consecutive patients ≥ 14 years with ANP will be enrolled at four tertiary hospitals from Novemeber 2025 to December 2026. If validated, this single-blood approach could enable early, pathogen-directed therapy, curtail unnecessary antibiotics and expedite surgical timing in ANP.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| definite IPN group | A positive culture of pancreatic or peripancreatic necrotic tissue obtained from the first drainage procedure or operation, or the presence of gas in the fluid collection on contrast-enhanced CT. | |
| clinical sterile pancreatic necrosis(SPN) group | Clinically stable during hospitalization with no intervention indicated and the blinded reviewers, after exhaustive chart review, identified no objective evidence of pancreatic infection. | |
| definite SPN group | The same specimen remained sterile after standard aerobic, anaerobic, and fungal culture. | |
| suspected IPN group | (i) Infectious manifestations occurred during hospitalization, but such manifestations could be cured with antibiotics alone without the need of any surgical intervention (ii) Infectious manifestations emerged during the disease course, and definitive indications for surgical intervention were identified; nonetheless, surgical intervention was not performed during hospitalization, which was attributed to factors including the patient's demise; (iii) No infectious signs emerged during the disease course, but the patient died of massive hemorrhage or multiple organ failure before any invasive procedure could be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN.
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Jan 2026 (estimated)
- Primary completion1 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 Acute Necrotizing PancreatitisStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, LiuZhou People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308600
- Sponsor's protocol ID
- 2025040636
- Acronym
- PROMOTE
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Plasma Metagenomics and Host Response for Accurate Diagnosis of Infected Pancreatic Necrosis in a Prospective Multicenter Cohort of Acute Necrotizing Pancreatitis
- ClinicalTrials.gov ID
- NCT07308600
- Acronym / sponsor ID
- PROMOTE / 2025040636
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, LiuZhou People's Hospital
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Dec 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.
This study is being done to find a faster and more accurate way to tell whether the necrosis in patients with acute necrotizing pancreatitis (ANP) has become infected. In the absence of microbiological confirmation, clinicians often have to initiate empirical antibiotic therapy for suspected pancreatic infection-a practice supported by current guidelines but one that may contribute to antimicrobial resistance. In this study, the investigators will combine metagenomic next-generation sequencing (mNGS) which could improve the accuracy of infected pancreatic necrosis (IPN) diagnosis and host transcriptional response analysis which could discriminate infectious and noninfectious inflammatory syndromes. In a prospective, multicentre, cohort study, 200 consecutive patients ≥ 14 years with ANP will be enrolled at four tertiary hospitals from Novemeber 2025 to December 2026. If validated, this single-blood approach could enable early, pathogen-directed therapy, curtail unnecessary antibiotics and expedite surgical timing in ANP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| definite IPN group | – | –A positive culture of pancreatic or peripancreatic necrotic tissue obtained from the first drainage procedure or operation, or the presence of gas in the fluid collection on contrast-enhanced CT. |
| clinical sterile pancreatic necrosis(SPN) group | – | –Clinically stable during hospitalization with no intervention indicated and the blinded reviewers, after exhaustive chart review, identified no objective evidence of pancreatic infection. |
| definite SPN group | – | –The same specimen remained sterile after standard aerobic, anaerobic, and fungal culture. |
| suspected IPN group | – | –(i) Infectious manifestations occurred during hospitalization, but such manifestations could be cured with antibiotics alone without the need of any surgical intervention (ii) Infectious manifestations emerged during the disease course, and definitive indications for surgical intervention were identified; nonetheless, surgical intervention was not performed during hospitalization, which was attributed to factors including the patient's demise; (iii) No infectious signs emerged during the disease course, but the patient died of massive hemorrhage or multiple organ failure before any invasive procedure could be performed. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute necrotizing pancreatitis from Xiangya Hospital Central South University, Affiliated Hospital of Guizhou Medical University, Liuzhou People's Hospital, Hunan University of Medicine General Hospital.
Key inclusion criteria (3 listed)
- Confirmed acute necrotizing pancreatitis (Revised Atlanta 2012) within 48 h of symptom onset
- Age ≥14 years
- Written informed consent
Key exclusion criteria (4 listed)
- Invasive interventions including percutaneous catheter drainage (PCD) and surgical necrosectomy have already been performed prior to admission.
- Confirmed infection outside of pancreas, including pulmonary infection, urinary tract infection.
- Pregnancy .
- Acute recurrent pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN.
Time frame: through study completion, an average of 2 months
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 8 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis, run by Xiangya Hospital of Central South University.
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 4 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN. (time frame: through study completion, an average of 2 months). 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 8 Jan 2026.