Integrating Plasma Metagenomics and Host Response for Accurate Diagnosis of Infected Pancreatic Necrosis in a Prospective Multicenter Cohort of Acute Necrotizing Pancreatitis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorXiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed acute necrotizing pancreatitis (Revised Atlanta 2012) within 48 h of symptom onset

Age ≥14 years

Written informed consent

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 4 trial groups
Group A: definite IPN group
Group B: clinical sterile pancreatic necrosis(SPN) group
Group C: definite SPN group
Group D: suspected IPN group

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN.

Time frame
through study completion, an average of 2 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangya Hospital of Central South University

Lead sponsor

The Affiliated Hospital Of Guizhou Medical University

Collaborator

LiuZhou People's Hospital

Collaborator

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