Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis

NCT ID: NCT02602808

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1097 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-12-31

Brief Summary

It is important to identify patients with acute pancreatitis who are at risk for developing persistent organ failure early in the course of disease. The investigators evaluated whether peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could serve as a good marker for detection of acute pancreatitis with persistent organ failure at early phase.

Detailed Description

Acute pancreatitis is a sudden inflammation of the pancreas. It can have severe complications and high mortality despite treatment. While mild cases are often successfully treated with conservative measures, such as fasting and aggressive intravenous fluid rehydration, severe cases may require admission to the intensive care unit or even surgery to deal with complications of the disease process. The diagnosis of severe acute pancreatitis at an early phase remain a major challenge for clinicians.

Therefore, many biologic markers have been studied in an effort to improve the diagnostic rate and determine the severity of acute pancreatitis but with disappointing results. Non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), have recently been validated to stably exist in peripheral blood. Several publications showed that it may serve as potential markers for various diseases, including cancer and inflammation. Our current study evaluated whether and which kind of non-coding RNAs could serve as good markers for severe acute pancreatitis.

Conditions

Acute Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Severe acute pancreatitis group

Severe acute pancreatitis is characterised by persistent organ failure.

No interventions assigned to this group

Moderately severe acute pancreatitis

Moderately severe acute pancreatitis is characterised by the presence of transient organ failure or local or systemic complications in the absence of persistent organ failure.

No interventions assigned to this group

Mild acute pancreatitis

Mild acute pancreatitis is characterised by the absence of organ failure and the absence of local or systemic complications.

No interventions assigned to this group

post-ERCP pancreatitis

Patients with new onset of epigastric pain, an increase in pancreatic enzymes of at least three times the upper limit of the normal range within 24 hours after ERCP, and hospitalization for at least 2 nights.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients who was diagnosed acute pancreatitis
• Male or female
• 18 Years and older
• written informed consent

Exclusion Criteria

• Symptoms of acute pancreatitis present for more than 72 hours
• Age under 18 years
• Pregnancy
• patients unable to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

Director of gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoshen Li, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Linyi People's Hospital

Linyi, Shandong, China

Changhai Hospital, Second Military Medical University

Shanghai, , China

Department of Gastroenterology, Shanghai First People's Hospital

Shanghai, , China

Countries

China

References

Zhu H, Zhou X, Sun X, Fu C, Li G, Dong X, Kong X, Su X, Du Y. Serum Exosomal miR-216a Contributes to Acute Pancreatitis-Associated Acute Lung Injury by Enhancing Endothelial Cell Vascular Permeability Through Downregulating LAMC1. Pancreas. 2025 Jul 1;54(6):e537-e546. doi: 10.1097/MPA.0000000000002467.

Reference Type: DERIVED

PMID: 39937877 (View on PubMed)

Li L, Zhang Q, Feng Y, Kong F, Sun F, Xie P, Zhao J, Yu H, Zhou J, Wu S, Zhao S, Li Z, Liu F, Du Y, Kong X. A Novel Serum Exosomal MicroRNA Signature in the Early Prediction of Persistent Organ Failure in Patients With Acute Pancreatitis. Ann Surg. 2025 Jul 1;282(1):93-99. doi: 10.1097/SLA.0000000000006229. Epub 2024 Feb 7.

Reference Type: DERIVED

PMID: 38323410 (View on PubMed)

Other Identifiers

Pancreatitis Markers

Identifier Type: -

Identifier Source: org_study_id