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Acute PancreatitisNCRNAPNCT02602808

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

An observational study of Acute Pancreatitis, run by Changhai Hospital at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Pancreatitis
How many people
1,097 participants
Where
3 sitesChina
Study dates
Dec 2015to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients 18 years of age or older who were hospitalized in our hospital with acute pancreatitis.

Who may be able to join

  • Patients who was diagnosed acute pancreatitis
  • Male or female
  • 18 Years and older
  • written informed consent

Who cannot join

  • Symptoms of acute pancreatitis present for more than 72 hours
  • Age under 18 years
  • Pregnancy
  • patients unable to consent

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Linyi People's Hospital

    Linyi, Shandong

  • Changhai Hospital, Second Military Medical University

    Shanghai, 200433

  • Department of Gastroenterology, Shanghai First People's Hospital

    Shanghai, 200433

Other trials in China

About this study

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.

Read the 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.

Keywords
acute pancreatitis, non-coding RNA, biological markers, receiver operating characteristic curve, post-ERCP pancreatitis
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02602808
Study groupRoleWhat they receive
Severe acute pancreatitis groupSevere acute pancreatitis is characterised by persistent organ failure.
Moderately severe acute pancreatitisModerately 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 pancreatitisMild acute pancreatitis is characterised by the absence of organ failure and the absence of local or systemic complications.
post-ERCP pancreatitisPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The level of non-coding RNAs in peripheral blood

    RNA quantification after extraction using RT-PCR

    Measured: At admission

Secondary outcomes (4)

  1. serum urea nitrogen

    serum urea nitrogen quantification

    Measured: At admission

  2. serum creatinine

    serum creatinine quantification

    Measured: At admission

  3. 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

    Measured: At admission

  4. 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

    Measured: At admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,097 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02602808
Sponsor's protocol ID
Pancreatitis Markers
Acronym
NCRNAP
Status last verified
Oct 2022
First submitted
9 Nov 2015
Last updated
19 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhu H, Zhou X, Sun X, Fu C, Li G, Dong X, Kong X, Su X, Du Y. Serum Exosomal miR-216a Contributes to Acute Pancreatitis-Associated Acute Lung Injury by Enhancing Endothelial Cell Vascular Permeability Through Downregulating LAMC1. Pancreas. 2025 Jul 1;54(6):e537-e546. doi: 10.1097/MPA.0000000000002467.

    PubMed 39937877

  • Li L, Zhang Q, Feng Y, Kong F, Sun F, Xie P, Zhao J, Yu H, Zhou J, Wu S, Zhao S, Li Z, Liu F, Du Y, Kong X. A Novel Serum Exosomal MicroRNA Signature in the Early Prediction of Persistent Organ Failure in Patients With Acute Pancreatitis. Ann Surg. 2025 Jul 1;282(1):93-99. doi: 10.1097/SLA.0000000000006229. Epub 2024 Feb 7.

    PubMed 38323410

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pancreatitis, run by Changhai Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The level of non-coding RNAs in peripheral blood (time frame: At admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02602808, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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