Acute Pancreatitis
Conditions
Brief summary
This study is a multicentric prospective study initiated and coordinated from the University Medical Centre Goettingen. The study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis.
Detailed description
This prospective translational study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis. From each patient one buccal and rectal swab is collected within 72 h after hospital admission. Microbial composition will be determined by 16S and metagenomics Oxford Nanopore Sequencing (ONT) and correlated with the revised Atlanta classification as the primary endpoint. Secondary endpoints are the correlation of microbiome signatures with the length of hospital stay, numbers of interventions and mortality. To this end, alpha and beta diversity of microbiota are determined and compared between mild, moderately severe and severe acute pancreatitis.
Interventions
DIAGNOSTIC_TESTRectal and buccal swabs
The oral and intestinal flora is collected from buccal and rectal swabs.
Sponsors
Department of Medicine II, University Hospital Rostock
Medical Department II, Division of Gastroenterology, University Hospital of Leipzig
Department of Medicine II, University Hospital, LMU Munich
Department of Medicine I, University Hospital of Halle
Department of Medicine A, University Medicine Greifswald
Department of Medicine II, University Hospital rechts der Isar, Technical University Munich
Department of Medical Bioinformatics, University Medical Center Göttingen
Department if Medical Statistics, University Medical Center Göttingen
University Medical Center Goettingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patients with acute pancreatitis (2 out of 3 following diagnostic criteria: lipase \>3x of upper limit, abdominal pain, and imaging modalities (computed tomography, magnetic resonance imaging or ultrasound). \< 72 hours after hospital admission.
Exclusion criteria
Pregnant women Patients \< 18 years; Patients who are incapable of giving consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Atlanta classification I-III | up to 8 weeks | Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | up to 12 months | days in hospital during initial admission |
| Numbers of interventions (surgical and endoscopical) | up to 12 months | number of percutaneous drainages, number of EUS-guided interventions of infected necrotic or acute collections, type of drainages (plastic versus lumen apposing metal stents), number of open surgical interventions |
| Mortality | up to 12 months | in hospital mortality during initial admission (%) |
Countries
Germany
Outcome results
None listed