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NCT Number: NCT07233551

Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.

Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Acute pancreatitis (AP) is a common disease that develops swiftly and has a mortality rate between 1% and 1.5%.

Investigators should therefore identify the severity of AP and the presence of complications early in order to reduce the risk of premature death and devise interventions to reduce mortality. Currently, the majority of conventional methods for assessing the severity of acute pancreatitis have limitations; the majority of these methods are insufficiently basic, rapid, and cost-effective. None of these methods are sufficiently sensitive or specific.

When acute pancreatitis occurs, trypsin is released and the exocrine function of the pancreas is activated, which destroys the pancreatic self-defence mechanism and exacerbates the damage and destruction of pancreatic cells. Consequently, the vascular endothelium is compromised, motor dystonia develops, vascular permeability increases, more leukocytes migrate to tissues, and coagulation systems are activated. Numerous inflammatory markers based on blood cell changes that were inexpensive and easily obtained during the early stages of hospitalisation were used to determine the severity of AP, including the red cell distribution width (RDW), neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet lymphocyte ratio (PLR), total calcium (TC), albumin-corrected calcium (ACC), and blood urea nitrogen (BUN). However, there is little literature that compares their predictive functions comprehensively.

Because inflammatory mediators play a crucial role in the occurrence of AP, numerous inflammatory markers have recently been used to predict the prognosis of AP. SII is one of the new inflammatory markers that indicates the immune status. SII is a measure of systemic immune-inflammation based on neutrophils, lymphocytes, and platelets. SII was previously only associated with the prognosis of cancer patients; however, it has recently been applied to inflammation-related diseases.

In patients with severe acute pancreatitis (AP), numerous pancreatic cells are damaged, and as a result, inadequate insulin secretion can result in stressful fluctuations in blood glucose level. Blood glucose fluctuations are believed to cause irreversible organ injury and impact patient prognosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients aged 18 years old or older.
  • patients with acute pancreatitis who were treated in our hospital from January 2019 to March 2025.

Exclusion criteria

  • history of chronic kidney disease
  • Pregnancy.
  • History of neoplasm
  • present of acute infection
  • history of hematological diseases

Treatment and study plan

CBC derived inflammatory indices

Other

Complete blood count, CBC_based inflammatory indices:

  • Prognostic nutritional index (PNI):

PNI is a score based on serum albumin and lymphocyte count, used to assess nutritional and immune status.

  • Systemic inflammation response index (SIRI) :

SIRI is an inflammatory marker used to assess systemic inflammation and predict prognosis in various diseases, including cancer and acute conditions.

  • Systemic immune inflammation index (SII) :

SII is a composite marker reflecting the balance between host immune and inflammatory status. It is widely used as a prognostic indicator in cancers, cardiovascular disease, and acute inflammatory conditions.

  • platelet lymphcyte ratio (PLR) : (PLR) reflects the balance between thrombosis/inflammation (platelets) and immune regulation (lymphocytes).
  • Neutrophile to lymphcyte ratio (NLR) :

(NLR) is a widely used inflammatory marker derived from CBC, indicating systemic inflammation and immune response.

Primary outcomes

  1. Correlation between Prognostic Nutritional Index (PNI) and Clinical Severity of Acute Pancreatitis

    Time frame: Between 48 and 72 hours after hospital admission

    PNI will be calculated as: PNI = 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (/mm³). The correlation between PNI (numeric value) and the clinical severity of acute pancreatitis (based on the Revised Atlanta Classification) will be assessed

  2. Correlation between Systemic Immune-Inflammation Index (SII) and Clinical Severity of Acute Pancreatitis

    Time frame: Between 48 and 72 hours after hospital admission

    SII will be calculated as: SII = (Platelet count × Neutrophil count) / Lymphocyte count. The correlation between SII (numeric value) and clinical severity will be assessed.

  3. Correlation between Systemic Inflammation Response Index (SIRI) and Clinical Severity of Acute Pancreatitis

    Time frame: Between 48 and 72 hours after hospital admission

    SIRI will be calculated as: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count. The correlation between SIRI (numeric value) and clinical severity will be assessed.

  4. Correlation between Platelet-to-Lymphocyte Ratio (PLR) and Clinical Severity of Acute Pancreatitis

    Time frame: Between 48 and 72 hours after hospital admission

    PLR will be calculated as: PLR = Platelet count / Lymphocyte count. The correlation between PLR (numeric ratio) and clinical severity will be assessed.

  5. Correlation between Neutrophil-to-Lymphocyte Ratio (NLR) and Clinical Severity of Acute Pancreatitis

    Time frame: Between 48 and 72 hours after hospital admission

    NLR will be calculated as: NLR = Neutrophil count / Lymphocyte count. The correlation between NLR (numeric ratio) and clinical severity will be assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelhameed Ahmed Abdelhameed, Master Degree

CONTACT

[email protected]

+201158933876

Mohamed Abozaid Ali, Doctorate

CONTACT

[email protected]

+201027027525

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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