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

NCT06867120 | Recruiting

• 1 other identifier: 2022-PUMCH-B-023
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 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

Acute Pancreatitis (AP); Severe Acute Pancreatitis

Keywords

bowel sound; acute pancreatitis; intestinal function; prediction

Outcome Measures

Primary Outcomes (1)

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

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

  Within 7 days after enrollment.

Secondary Outcomes (4)

• Number of participants with in-hospital mortality.

  Within 30 days after enrollment.

• Number of participants with 30-day mortality.

  Within 30 days after enrollment.

• Length of hospital stay.

  Within 30 days after enrollment.

• Number of participants with organ failure.

  Within 30 days after enrollment.

Study Arms (1)

Observational Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included AP patients admitted to the outpatient/emergency and inpatient wards of Peking Union Medical College Hospital, Beijing Sixth Hospital, and Beijing Longfu Hospital from December 2023 to December 2026.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Sixth Hospital: collaborator
• Beijing Longfu Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Ziying Han, Doctor of Medicine

CONTACT

+86 15811301605; hanziying@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: March 10, 2025
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)