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Acute Pancreatitis (AP)NCT06828965

Neutrophil-Creatinine Index in Patients with Acute Pancreatitis: Assessment of Severity and Outcome

An observational study of Acute Pancreatitis (AP), run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Acute pancreatitis is a disease that usually has a mild disease course. However, around 20-30% of the patients develop severe complications. Persistent organ failure, with or without the presence of local complications such as (peri-) pancreatic necrosis and secondary infections, is the main determinant for mortality… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Pancreatitis (AP)
What is being tested?
Neutrophil creatinine index
How many people
100 participants
Where
1 siteEgypt
Study dates
27 Mar 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Based on previous reported estimated proportion of severe acute pancreatitis that was 15-20% (Silva-Vaz et al., 2020, Heckler et al., 2021) in addition to probability error 5% and 80% power on a two-tailed test, a minimum of 84 patients with acute pancreatitis are needed as an effective sample size for the current issue. To avoid drop out, a total of 120 patients will be recruited. It was calculated by OpenEpi

Who may be able to join

  • All patients with AP will be enrolled.
  • Both sexes
  • Age of patient > 18 years old

Who cannot join

  • Age less than 18 years old
  • Pancreatic cancer
  • Picture of chronic pancreatitis
  • Recurrent pancreatitis
  • pregnancy, end-stage renal disease, hematological disorders, pancreatic carcinoma or cholangiocarcinoma, and incomplete records.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marwa Ahmed Abdelrahman, Master Degree contact

01201777557 ext. 002

m.hazem75@icloud.com

Mohammad Alyamany Kobeisy, PHD contact

01005509890 ext. 002

yamany1@med.aun.edu.eg

Egypt1 site
  • Assiut University Egypt

    Asyut, Asyut Governorate

Other trials in Egypt

About this study

Acute pancreatitis is a disease that usually has a mild disease course. However, around 20-30% of the patients develop severe complications. Persistent organ failure, with or without the presence of local complications such as (peri-) pancreatic necrosis and secondary infections, is the main determinant for mortality, and these patients are classified as having severe acute pancreatitis according to the revised Atlanta classification . The most widely used classification systems for determining the severity and course of AP are the revised Atlanta classification and the Bedside Index of Severity in Acute Pancreatitis (BISAP). According to the revised Atlanta classification, the severity of AP is graded as mild acute pancreatitis (MAP), moderately severe acute pancreatitis (MSAP), or severe acute pancreatitis (SAP) . In addition to the revised Atlanta classification and BISAP, several other prognostic scoring systems and classifications have been developed to predict the severity of AP. Ranson's criteria, the Acute Physiology and Chronic Health Evaluation (APACHE) II score, the Modified Glasgow Prognostic Score, and the Balthazar index are other commonly used prognostic systems . Most of these scoring systems include multiple determinants or parameters that must be noted 24 to 48 h after hospitalization, and the estimation of the severity of AP is delayed until 48 h after hospitalization. Thus, these scoring systems are of limited use at admission. On the other hand, in view of the complexity of prognostic scoring systems, several studies have been conducted on the role of simple laboratory parameters and indices in predicting the disease severity of AP and mortality . The most widely studied laboratory parameters and indices are the white blood cell count (WBC), neutrophil count, neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), C-reactive protein (CRP), and procalcitonin. These laboratory parameters have also been used as part of several prognostic scoring systems. Nevertheless, none of the laboratory parameters or prognostic scoring systems can predict the severity of AP or MOF with sufficient accuracy . Moreover, it is not easy to predict the course and severity of acute pancreatitis at the first assessment of hospital admission. At the time of admission, most laboratory parameters are insufficient to differentiate mild disease from severe disease, and changes in laboratory parameters over time, including inflammatory markers and parameters related to organ/system dysfunction, provide important clues regarding the course of the disease . On the other hand, there is a need for simple, reliable, widely used parameters at admission for predicting the course of the disease. Sahin (2024) found a new index named the neutrophil-creatinine index (NCI), which was established based on the levels of neutrophil count and creatinine, to predict the severity of AP at admission . It's known that neutrophil infiltration and activation is one of the early events in acute pancreatitis and results in higher neutrophil count values at admission. Similarly, higher creatinine values at admission indicate renal hypoperfusion, which is associated with third-space leakage resulting from a systemic inflammatory state. It was assumed that the NCI may serve as an efficient test to represent the combination of inflammatory response and organ dysfunction .

Read the detailed description

Inclusion criteria

  • All patients with AP will be enrolled.
  • Both sexes
  • Age of patient > 18 years old Exclusion criteria Any patient with one or more of the following criteria is excluded;
  • Age less than 18 years old
  • Pancreatic cancer
  • Picture of chronic pancreatitis
  • Recurrent pancreatitis
Being tested
Neutrophil creatinine index
Keywords
acute pancreatitis, severity, accuracy, mortality
Medical subject headings
Pancreatitis

What participants receive

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

  • Neutrophil creatinine indexOther

    Neutrophil creatinine index will be calculated

  • Neutrophil creatinine indexOther

    Neutrophi creatinine index will be calculated in all patients

What is being measured

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

  1. Accuracy of neutrophil/creatinine index in prediction severity of acute pancreatitis

    A receiver operator characteristics curve will be used to determine the cut-off point of neutrophil/creatinine index in prediction severity of acute pancreatitis

    Measured: One year

Timeline

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

  1. First posted17 Feb 2025
  2. Study start27 Mar 2025 (estimated)
  3. Primary completion27 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828965
Sponsor's protocol ID
Marwa protocol
Status last verified
Feb 2025
First submitted
27 Jan 2025
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Till finishing the study

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pancreatitis (AP), run by Assiut University at 1 site in Egypt.

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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Marwa Ahmed Abdelrahman, Master Degree (01201777557 ext. 002, m.hazem75@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of neutrophil/creatinine index in prediction severity of acute pancreatitis (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Feb 2025.

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