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

NCT02602808 | Completed DMC

• 1 other identifier: Pancreatitis Markers
• Study Type: observational
• Target: 1,097
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Pancreatitis

Keywords

acute pancreatitis; non-coding RNA; biological markers; receiver operating characteristic curve; post-ERCP pancreatitis

Outcome Measures

Primary Outcomes (1)

• The level of non-coding RNAs in peripheral blood

  RNA quantification after extraction using RT-PCR

  At admission

Secondary Outcomes (4)

• serum urea nitrogen

  At admission

• serum creatinine

  At admission

• APACHE II score at admission

  At admission

• BISAP score at admission

  At admission

Study Arms (4)

Severe acute pancreatitis group

Severe acute pancreatitis is characterised by persistent organ failure.

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.

Mild acute pancreatitis

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

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.

Eligibility Criteria

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

Study Population

All patients 18 years of age or older who were hospitalized in our hospital with acute pancreatitis.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (3)

Linyi People's Hospital

Linyi, Shandong, China

Location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Department of Gastroenterology, Shanghai First People's Hospital

Shanghai, 200433, China

Location

Related Publications (2)

• 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.

  PMID: 39937877 DERIVED

• 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.

  PMID: 38323410 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples were collected from patients within the first 24 h after hospital admission. Also, blood samples were collected from patients at the time point of 24 hr after ERCP procedure. Serum, plasma and blood cells was isolated after blood collection by centrifugation at room temperature.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Zhaoshen Li, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of gastroenterology department

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

CN (3)