NCT07308600

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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

• Acute Necrotizing Pancreatitis
• Infected Pancreatic Necrosis

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-12-01
• Completion: 2026-12-30
• First posted: 2025-12-29
• Last updated: 2026-01-08