Actively Recruiting
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
N/A
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
Researchers are evaluating a new way to predict severe acute pancreatitis (SAP) early in patients diagnosed with acute pancreatitis (AP). This study aims to monitor bowel sounds continuously to identify those likely to develop SAP, which has a poor prognosis. It is a prospective, multi-center study including patients newly diagnosed with AP at emergency departments across three centers starting from December 2023. Participants will undergo continuous bowel sound monitoring for at least 48 hours using standardized equipment. The bowel sounds will be analyzed by an automated algorithm to estimate an activity index that may indicate the risk of SAP. This monitoring is blinded to the patients' SAP status. The study also explores differences in gut microbiota and blood markers related to intestinal permeability between patients with and without SAP. During the study, researchers will track the occurrence of SAP within 7 days after enrollment as the primary outcome. They will also observe mortality, length of hospital stay, and organ failure up to 30 days. Participants will have their bowel sounds monitored continuously, and samples for gut microbiota and blood markers will be collected. This study helps assess intestinal function in AP patients and may improve early prognosis prediction. The total participation time varies based on hospitalization duration and monitoring needs.
CONDITIONS
Brief Title
Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 85 years old
- Diagnosed with acute pancreatitis by meeting at least two of the following: characteristic abdominal pain, serum amylase and lipase levels over three times normal, or typical abdominal imaging
- Acute pancreatitis onset within 48 hours
- Patient or family understands and agrees to the study by signing informed consent
You will not qualify if you...
- Serious conditions requiring surgery or abdominal lavage
- Pregnant women
- History of muscle or nerve disorders, chronic pancreatitis, inflammatory bowel disease, cancer, or irritable bowel syndrome
- Severe digestive, respiratory, cardiovascular, blood, endocrine, psychiatric, or infectious diseases
- History of abdominal surgery except appendectomy or cholecystectomy
- Allergy to silicone, polycarbonate materials, or medical plaster
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days after enrollment
Participants diagnosed with acute pancreatitis are observed to assess the severity of their condition during hospitalization.
Daily assessments during hospitalization
Duration - Up to 30 days after enrollment
Participants are followed up for 30 days after enrollment to monitor outcomes such as mortality and length of hospital stay.
Follow-up visits or contacts as needed within 30 days
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Ziying Han, Doctor of Medicine
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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