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

Completed

• Conditions: Acute Pancreatitis

• Registration Number: NCT02602808
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Study Start: 2015-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1097

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of non-coding RNAs in peripheral blood	At admission	RNA quantification after extraction using RT-PCR

Secondary Outcome Measures

Name	Time	Method
BISAP score at admission	At admission	BISAP socre determined by BUN (\>25 mg/dL), impaired mental status (Glasgow Coma Score \<15), SIRS (≥2), age (\>60 y), pleural effusion
serum urea nitrogen	At admission	serum urea nitrogen quantification
serum creatinine	At admission	serum creatinine quantification
APACHE II score at admission	At admission	APACHE II score determined by Temperature, MAP, heart rate, respiratory rate, Pao2, arterial pH, HCO3, sodium, potassium, creatinine, hematocrit, WBC, Glasgow Coma Score, age, chronic health points

Trial Locations

Locations (3)

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