Acute Pancreatitis (AP)NCT06867120
Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study
An observational study of Acute Pancreatitis (AP) and Severe Acute Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Pancreatitis (AP), Severe Acute Pancreatitis
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Ziying Han, Doctor of Medicine, +86 15811301605, hanziying@pumch.cn
About this 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.
Read more
Strengths and limitations of the study:
- Our research aims to monitor bowel sounds in real-time and dynamically, providing an objective tool for monitoring intestinal activity in AP patients.
- 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.
- 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.
- 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
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after enrollment.
Secondary outcomes (4)
Number of participants with in-hospital mortality.
Number of participants who died during hospitalization.
Measured: Within 30 days after enrollment.
Number of participants with 30-day mortality.
Number of participants who died within 30 days after enrollment.
Measured: Within 30 days after enrollment.
Length of hospital stay.
The number of days participants stayed in the hospital.
Measured: Within 30 days after enrollment.
Number of participants with organ failure.
Number of participants who developed organ failure.
Measured: Within 30 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 352 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Sixth Hospital, Beijing Longfu Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867120
- Sponsor's protocol ID
- I-25PJ1400
- Status last verified
- Mar 2026
- First submitted
- 25 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han Z, Li J, Xu H, Kong F, Chen Y, Cai Y, Jiang Q, Shi D, Wu D. Bowel sound in predicting the severity of acute pancreatitis: Protocol of a prospective, multi-center study. PLoS One. 2026 Oct 13;21(10):e0358660. doi: 10.1371/journal.pone.0358660. eCollection 2026.
PubMed 42868116
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study
- ClinicalTrials.gov ID
- NCT06867120
- Acronym / sponsor ID
- I-25PJ1400
- Conditions
- Acute Pancreatitis (AP), Severe Acute Pancreatitis
- Keywords
- bowel sound, acute pancreatitis, intestinal function, prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Sixth Hospital, Beijing Longfu Hospital
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Our research aims to monitor bowel sounds in real-time and dynamically, providing an objective tool for monitoring intestinal activity in AP patients.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Number of participants with in-hospital mortality.
Time frame: Within 30 days after enrollment.
Number of participants with 30-day mortality.
Time frame: Within 30 days after enrollment.
Length of hospital stay.
Time frame: Within 30 days after enrollment.
Number of participants with organ failure.
Time frame: Within 30 days after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 42868116Han Z, Li J, Xu H, Kong F, Chen Y, Cai Y, Jiang Q, Shi D, Wu D. Bowel sound in predicting the severity of acute pancreatitis: Protocol of a prospective, multi-center study. PLoS One. 2026 Oct 13;21(10):e0358660. doi: 10.1371/journal.pone.0358660. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis (AP) and Severe Acute Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziying Han, Doctor of Medicine (+86 15811301605, hanziying@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with severe acute pancreatitis (SAP) during hospitalization within 7 days after enrollment. (time frame: Within 7 days after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.