Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06867120

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

Led by Peking Union Medical College Hospital · Updated on 2026-04-06

352

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

P

Peking Union Medical College Hospital

Lead Sponsor

B

Beijing Sixth Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 85 years old
  • Diagnosed with acute pancreatitis by at least two of the following: characteristic abdominal pain, serum amylase and lipase levels over three times the normal limit, or typical abdominal imaging findings
  • Acute pancreatitis onset within 48 hours
  • Patient or family members understand the study and sign informed consent
Not Eligible

You will not qualify if you...

  • Serious conditions requiring surgery and abdominal lavage
  • Pregnant women
  • History of muscle and nerve disorders, chronic pancreatitis, inflammatory bowel disease, cancer, or irritable bowel syndrome
  • Severe digestive, respiratory, cardiovascular, hematological, endocrine, psychiatric, or infectious diseases
  • History of abdominal surgery except appendectomy or cholecystectomy
  • Allergic to silicone, polycarbonate materials, or medical plaster

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

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Research Team

Z

Ziying Han, Doctor of Medicine

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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