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

Acute Pancreatitis Clinical Trial

— NCRNAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602808
• Other study ID #: Pancreatitis Markers
• Status: Completed
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1097
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
China	Linyi People's Hospital	Linyi	Shandong
China	Changhai Hospital, Second Military Medical University	Shanghai
China	Department of Gastroenterology, Shanghai First People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of non-coding RNAs in peripheral blood	RNA quantification after extraction using RT-PCR	At admission
Secondary	serum urea nitrogen	serum urea nitrogen quantification	At admission
Secondary	serum creatinine	serum creatinine quantification	At admission
Secondary	APACHE II score 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	At admission
Secondary	BISAP score at admission	BISAP socre determined by BUN (>25 mg/dL), impaired mental status (Glasgow Coma Score <15), SIRS (=2), age (>60 y), pleural effusion	At admission