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| Name | Class |
|---|---|
| Beijing Sixth Hospital | UNKNOWN |
| Beijing Longfu Hospital | UNKNOWN |
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Introduction: Acute pancreatitis (AP) is a common condition, with 20% of cases progressing to severe acute pancreatitis (SAP), which is associated with a poor prognosis. Early identification of patients likely to progress to SAP is crucial for timely intervention. This study aims to use bowel sound monitoring to predict early progression to SAP in AP patients.
Methods and analysis: This study is a prospective, multi-center prognostic study . Investigators will consecutively recruit newly diagnosed acute pancreatitis (AP) patients at emergency departments across three centers from December 2023. Upon enrollment, each patient will undergo continuous bowel sound monitoring for at least 48 hours using standardized equipment and procedures. The primary outcome is the occurrence of SAP during hospitalization. Collected bowel sound data will be analyzed by an unsupervised automated algorithm to estimate a bowel sound activity index, which serves as the main diagnostic indicator for SAP. This process will be fully blinded to patients' SAP status. Investigators will calculate the ROC curve and area under the curve (AUC) for the bowel sound activity index's ability to diagnose SAP. Additionally, this study will perform exploratory analyses on differences in gut microbiota and serum intestinal permeability markers (diamine oxidase, D-lactic acid, and bacterial endotoxin) between patients with and without SAP. Investigators will also assess whether bowel sound monitoring can reflect these inter-group differences.
Strengths and limitations of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with severe acute pancreatitis (SAP) during hospitalization within 7 days after enrollment. | SAP was defined as AP patients with persistent organ failure according to the revised Atlanta classification. | Within 7 days after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with in-hospital mortality. | Number of participants who died during hospitalization. | Within 30 days after enrollment. |
| Number of participants with 30-day mortality. | Number of participants who died within 30 days after enrollment. |
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Inclusion criteria:
Exclusion criteria:
The patients who fulfill any of the following criteria will be excluded:
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This study included AP patients admitted to the outpatient/emergency and inpatient wards of Peking Union Medical College Hospital, Beijing Sixth Hospital, and Beijing Longfu Hospital from December 2023 to December 2026.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziying Han, Doctor of Medicine | Contact | +86 15811301605 | hanziying@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Within 30 days after enrollment. |
| Length of hospital stay. | The number of days participants stayed in the hospital. | Within 30 days after enrollment. |
| Number of participants with organ failure. | Number of participants who developed organ failure. | Within 30 days after enrollment. |