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Application of metagenomic next-generation sequencing in microbial diagnosis of pancreatic necrotic tissue infection: a diagnostic test

Application of metagenomic next-generation sequencing in microbial diagnosis of pancreatic necrotic tissue infection: a diagnostic test

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047244
Enrollment
Unknown
Registered
2021-06-11
Start date
2021-06-15
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe acute pancreatitis

Interventions

Gold Standard:Gold Standard :The clinical manifestations of infection such as persistent fever were found, and the microorganism culture obtained by fine needle puncture or first invasive drainage (p

Sponsors

Jinling Hospital affiliated to Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for acute pancreatitis in the 2012 Atlanta diagnostic criteria for acute pancreatitis; 2. Aged >=18 years; 3. Patients with AP admitted within 1 week of onset; 4. Necrosis of the pancreas and/or peripancreatic tissue visible on enhanced CT scan; 5. Suspected infected pancreatic necrosis(meets 1 of the following): (1) Body temperature >= 38.5 degree for more than 3 days; (2) Elevated PCT and CRP(PCT> 2ng/ml and CRP>120mg). 6.Informed consent form obtained from the patient or next of kin.

Exclusion criteria

Exclusion criteria: 1. Pregnant pancreatitis; 2. Infected necrosis is diagnosed by gas in the necrotic collection on imaging; 3. Receiving intervention or early surgery due to abdominal compartment syndrome or other reasons before admission; 4. known reason of other infectious disease; 5. Patients with preexisting immune disorders; 6. Discharge or death within 48h of anticipated inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Diagnostic efficacy (including sensitivity, specificity, positive predictive value, and negative predictive value);

Secondary

MeasureTime frame
Cure rates with conservative treatment;Proportion of minimally invasive debridement or open surgery;Days of antibiotic use;local complications rate;bleeding events rate;sepsis rate and septic shock rate;new onset organ failure rate;Worsened organ failure rate;organ failure free days within 28 days of enrollment;C-reactive protein, procalcitonin, IL-6;Length of stay in intensive care ward;hospital length of stay;

Countries

China

Contacts

Public ContactLi Weiqin

Jinling Hospital affiliated to Nanjing University

ctgchina@medbit.cn+86 13951839654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026