Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study

Recruiting

• Conditions: Acute Pancreatitis (AP); Severe Acute Pancreatitis

• Registration Number: NCT06867120
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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:

1. Our research aims to monitor bowel sounds in real-time and dynamically, providing an objective tool for monitoring intestinal activity in AP patients.

2. Our research might offer an objective tool to evaluate bowel sounds, aiding in assessing AP patients' intestinal function and complementing existing score systems like the modified Marshall score.

3. By detecting bowel sounds in the early stage of AP, investigators could better monitor intestinal function, which might aid in predicting the prognosis of AP patients.

4. Our monitoring system's main limitation is its difficulty in pinpointing bowel sound changes in specific intestinal segments due to its detection across the entire abdomen.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with severe acute pancreatitis (SAP) during hospitalization within 7 days after enrollment.	Within 7 days after enrollment.	SAP was defined as AP patients with persistent organ failure according to the revised Atlanta classification.

Secondary Outcome Measures

Name	Time	Method
Number of participants with in-hospital mortality.	Within 30 days after enrollment.	Number of participants who died during hospitalization.
Number of participants with 30-day mortality.	Within 30 days after enrollment.	Number of participants who died within 30 days after enrollment.
Length of hospital stay.	Within 30 days after enrollment.	The number of days participants stayed in the hospital.
Number of participants with organ failure.	Within 30 days after enrollment.	Number of participants who developed organ failure.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China