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NCT Number: NCT06867120

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Ziying Han, Doctor of Medicine

CONTACT

[email protected]

+86 15811301605

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 85 years old.
  • Meet the diagnostic criteria for AP, at least two of the following three: (a) characteristic abdominal pain; (b) serum amylase and lipase levels are greater than three times the upper limit of normal; (c) abdominal images with typical manifestations of AP.
  • AP patients within 48 hours of onset.
  • The patient or family members understand the study protocol and sign the informed consent form.

Exclusion criteria

The patients who fulfill any of the following criteria will be excluded:

  • Patients with serious conditions requiring surgery and abdominal lavage.
  • Pregnant women.
  • The patients with muscle and nerve disorders, chronic pancreatitis, inflammatory bowel disease, cancer, and irritable bowel syndrome.
  • The patients with severe digestive, respiratory, cardiovascular, hematological, endocrine, psychiatric, and infectious diseases.
  • The patients have a history of abdominal surgery (except appendectomy or cholecystectomy).
  • Allergic to silicone, polycarbonate materials or medical plaster. The intake of antibiotic, probiotics, and Chinese herbal medicine will be recorded before the collection of the swabs and will not be considered as exclusion criteria.

Treatment and study plan

Primary outcomes

  1. Number of participants with severe acute pancreatitis (SAP) during hospitalization within 7 days after enrollment.

    Time frame: Within 7 days after enrollment.

    SAP was defined as AP patients with persistent organ failure according to the revised Atlanta classification.

Secondary outcomes

  1. Number of participants with in-hospital mortality.

    Time frame: Within 30 days after enrollment.

    Number of participants who died during hospitalization.

  2. Number of participants with 30-day mortality.

    Time frame: Within 30 days after enrollment.

    Number of participants who died within 30 days after enrollment.

  3. Length of hospital stay.

    Time frame: Within 30 days after enrollment.

    The number of days participants stayed in the hospital.

  4. Number of participants with organ failure.

    Time frame: Within 30 days after enrollment.

    Number of participants who developed organ failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Ziying Han, Doctor of Medicine

CONTACT

[email protected]

+86 15811301605

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Longfu Hospital
  • Beijing Sixth Hospital

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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