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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602808
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, 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.

Condition or disease
Acute Pancreatitis

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.

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Study Type : Observational
Actual Enrollment : 1097 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort
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.



Primary Outcome Measures :
  1. The level of non-coding RNAs in peripheral blood [ Time Frame: At admission ]
    RNA quantification after extraction using RT-PCR


Secondary Outcome Measures :
  1. serum urea nitrogen [ Time Frame: At admission ]
    serum urea nitrogen quantification

  2. serum creatinine [ Time Frame: At admission ]
    serum creatinine quantification

  3. 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

  4. 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
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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients 18 years of age or older who were hospitalized in our hospital with acute pancreatitis.
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

Information from the National Library of Medicine

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


Locations
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China, Shandong
Linyi People's Hospital
Linyi, Shandong, China
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Department of Gastroenterology, Shanghai First People's Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Zhaoshen Li, MD Changhai Hospital
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Responsible Party: Zhaoshen Li, Director of gastroenterology department, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02602808    
Other Study ID Numbers: Pancreatitis Markers
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoshen Li, Changhai Hospital:
acute pancreatitis
non-coding RNA
biological markers
receiver operating characteristic curve
post-ERCP pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases