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

Central South University

Status: Not yet enrolling

Conditions: Acute Necrotizing Pancreatitis; Infected Pancreatic Necrosis

Study type: Observational

Funder types: Other

Identifiers

NCT07308600

2025040636

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed acute necrotizing pancreatitis (Revised Atlanta 2012) within 48 h of symptom onset
2. Age ≥14 years
3. Written informed consent

Exclusion criteria

1. Invasive interventions including percutaneous catheter drainage (PCD) and surgical necrosectomy have already been performed prior to admission.
2. Confirmed infection outside of pancreas, including pulmonary infection, urinary tract infection.
3. Pregnancy .
4. Acute recurrent pancreatitis

Trial design

200 participants in 4 patient groups

definite IPN group

Description:

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

Description:

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

Description:

The same specimen remained sterile after standard aerobic, anaerobic, and fungal culture.

suspected IPN group

Description:

(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.