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

NCT07308600 | Not Yet Recruiting

• 1 other identifier: 2025040636
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Infected Pancreatic Necrosis; Acute Necrotizing Pancreatitis

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 2 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• LiuZhou People's Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 29, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-11