Clinical trial NCT02602808: Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis
Official title: Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis
non-coding RNA
biological markers
receiver operating characteristic curve
post-ERCP pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 1097
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients 18 years of age or older who were hospitalized in our hospital with acute pancreatitis.

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.

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

Primary outcomes:
measure: The level of non-coding RNAs in peripheral blood
timeFrame: At admission
Secondary outcomes:
measure: serum urea nitrogen
timeFrame: At admission
measure: serum creatinine
timeFrame: At admission
measure: APACHE II score at admission
timeFrame: At admission
measure: BISAP score at admission
timeFrame: At admission
Other outcomes:
Locations:
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
city: Shanghai
country: China
facility: Department of Gastroenterology, Shanghai First People's Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References: