Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis (NCRNAP)
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|ClinicalTrials.gov Identifier: NCT02602808|
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : September 9, 2019
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||1097 participants|
|Official Title:||Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
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.
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.
- The level of non-coding RNAs in peripheral blood [ Time Frame: At admission ]RNA quantification after extraction using RT-PCR
- serum urea nitrogen [ Time Frame: At admission ]serum urea nitrogen quantification
- serum creatinine [ Time Frame: At admission ]serum creatinine quantification
- APACHE II score at admission [ Time Frame: 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
- BISAP score at admission [ Time Frame: At admission ]BISAP socre determined by BUN (>25 mg/dL), impaired mental status (Glasgow Coma Score <15), SIRS (≥2), age (>60 y), pleural effusion
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602808
|Linyi People's Hospital|
|Linyi, Shandong, China|
|Changhai Hospital, Second Military Medical University|
|Shanghai, China, 200433|
|Department of Gastroenterology, Shanghai First People's Hospital|
|Shanghai, China, 200433|
|Principal Investigator:||Zhaoshen Li, MD||Changhai Hospital|