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

November 17, 2025 updated by: Abdelhameed Ahmed Abdelhameed, Assiut University
Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with AP who were treated in our hospital (Al Rhaghe hospital) from January 2019 to March 2025 (age ≥18 years old; written consent will be obtained); also, we prospectively will analyse data of patients with AP who will be admitted within one year

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. history of chronic kidney disease
  2. Pregnancy.
  3. History of neoplasm
  4. present of acute infection
  5. history of hematological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between 48 and 72 hours after hospital admission
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.
Between 48 and 72 hours after hospital admission
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.
Between 48 and 72 hours after hospital admission
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.
Between 48 and 72 hours after hospital admission
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
Between 48 and 72 hours after hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP Prognosis with IF indices

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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