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

Recruitingn/aAges 18 Years - 85 YearsAllPeking Union Medical College Hospital
NCT06867120 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion criteria: 1. Aged between 18 and 85 years old. 2. 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. 3. AP patients within 48 hours of onset. 4. 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: 1. Patients with serious conditions requiring surgery and abdominal lavage. 2. Pregnant women. 3. The patients with muscle and nerve disorders, chronic pancreatitis, inflammatory bowel disease, cancer, and irritable bowel syndrome. 4. The patients with severe digestive, respiratory, cardiovascular, hematological, endocrine, psychiatric, and infectious diseases. 5. The patients have a history of abdominal surgery (except appendectomy or cholecystectomy). 6. 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.
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What it tests

  • Not listed
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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