Using bowel sounds to predict severe acute pancreatitis

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

This study is testing if monitoring bowel sounds can help doctors predict which patients with acute pancreatitis might develop severe complications.

Quick facts

• Study type: Observational
• Enrollment: 352 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06867120 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify patients with acute pancreatitis (AP) who are at risk of progressing to severe acute pancreatitis (SAP) by monitoring bowel sounds. Conducted across multiple centers, the study will enroll newly diagnosed AP patients and utilize continuous bowel sound monitoring for at least 48 hours. An automated algorithm will analyze the collected data to create a bowel sound activity index, which will serve as a diagnostic indicator for predicting the occurrence of SAP during hospitalization.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have been diagnosed with acute pancreatitis within 48 hours of onset.

Not a fit: Patients with serious conditions requiring surgery, chronic pancreatitis, or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enable earlier interventions for patients at risk of severe acute pancreatitis, potentially improving outcomes.

How similar studies have performed: While the use of bowel sounds in this context is relatively novel, similar prognostic approaches have shown promise in other conditions.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ziying Han, Doctor of Medicine

Conditions: Acute Pancreatitis, Severe Acute Pancreatitis, bowel sound, acute pancreatitis, intestinal function, prediction