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

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02602808

Collaborator

(none)

1,097

Enrollment

Locations

Actual Duration (Months)

365.7

Patients Per Site

10.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Dec 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

The level of non-coding RNAs in peripheral blood [At admission]
RNA quantification after extraction using RT-PCR

Secondary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linyi People's Hospital	Linyi	Shandong	China
2	Changhai Hospital, Second Military Medical University	Shanghai		China	200433
3	Department of Gastroenterology, Shanghai First People's Hospital	Shanghai		China	200433