Infected walled-off necrosis
Conditions
Interventions
None listed
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Diagnosed with infected walled-off necrosis (WON) 3. Scheduled for endoscopic treatment including necrosectomy or drainage 4. Able to provide written informed consent (patients with severely impaired consciousness at or shortly after admission may be enrolled via opt-out procedure)
Exclusion criteria
Exclusion criteria: 1. Age under 18 years 2. Patients who have explicitly refused participation in the study 3. Patients deemed inappropriate for participation at the investigator's discretion 4. Patients in whom specimen collection is judged medically difficult or inappropriate due to severe systemic condition or organ failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Longitudinal changes in bacterial microbiome composition (alpha diversity, beta diversity, and taxonomic profiles assessed by 16S rRNA gene amplicon sequencing) and microbial metabolite profiles (assessed by untargeted LC-MS/MS metabolomics) in necrotic tissue collected at each necrosectomy procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Association between antibiotic/antifungal use (type and duration) and longitudinal changes in microbiome composition. 2. Fungal microbiome composition assessed by ITS1 sequencing and the impact of antifungal therapy. 3. Concordance rate between conventional culture-based pathogen identification and 16S rRNA gene sequencing. 4. Association between microbiome/metabolome profiles and clinical outcomes (treatment success rate, in-hospital mortality, and major complication rates). 5. Detection and quantitative evaluation of antimicrobial resistance genes in necrotic tissue. | — |
Countries
Japan
Contacts
Public ContactToshiyuki Kishida
The University of Tokyo Hospital Department of Infectious Diseases
Outcome results
None listed