Neutrophil/Lymphocyte Ratio in Acute Pancreatitis

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05859633
Collaborator
(none)
100
1
7.1
14.2

Study Details

Study Description

Brief Summary

Acute pancreatitis (AP) is a disease characterized by dysfunction of pancreatic acinar cells, improper activation of trypsin, and subsequent destruction of pancreatic self-defense mechanisms, further exacerbating injury and damage of pancreatic cells. It is a rapidly developing inflammatory process of the pancreas, and the most common reasons are alcohol and gallstones.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Neutrophil/Lymphocyte Ratio in acute pancreatitis

Detailed Description

As one of the most common gastrointestinal diseases in hospitalized patients, the incidence of AP has gradually increased and is 4.9 to 73.4 cases per 100,000 people worldwide in the past few decades, imposing a heavy burden on the health system and leading to long-term hospitalization, most medical costs, and significant mortality.

Up to 10% to 20% of AP patients will develop SAP, and the leading cause of poor prognosis in patients with AP is a vital organ (cardiovascular organs, lung, and kidney) failure and pancreatic necrosis . In clinical practice, varieties of scoring systems are available and have been gradually confirmed, such as the Ranson score, Glasgow score, Acute Physiology and Chronic Health Evaluation (APACHE II), BISAP, and computed tomography severity index (CTSI) . These systems are cumbersome and take a long time to operate, requiring a lot of parameters that are not routinely collected in the early stages of the disease. For example, the BISAP score is characterized by high specificity, but its sensitivity to SAP is not satisfied. Therefore, their early prediction power is not good.

In AP, inflammation first activates a series of inflammatory cytokines, proteolytic enzymes, and anaerobic radioactive nucleic acids to destroy the tissue. The degree of neutrophils decrease is related to the improvement of prognosis of AP, while the degree of lymphocyte increase is related to the severity of the disease. The neutrophil-lymphocyte ratio (NLR) is a more comprehensive biomarker that used neutrophil and lymphocyte counts to respond rapidly to the extent of inflammatory progression and serves as a useful predictive marker to identify the severity of AP. It is well known that AP is a fast-onset inflammation of the pancreas, and an effective prediction of the severity of AP can guide AP patients to receive adequate treatment earlier, contributing to a better prognosis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Neutrophil/Lymphocyte Ratio in Predicting the Severity of Acute Pancreatitis
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with acute pancreatitis

any patient suffers from acute pancreatitis

Diagnostic Test: Neutrophil/Lymphocyte Ratio in acute pancreatitis
role of Neutrophil/Lymphocyte Ratio in acute pancreatitis

Outcome Measures

Primary Outcome Measures

  1. severe acute pancreatitis [one year]

    frequency of severe acute pancreatitis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with acute pancreatitis
Exclusion Criteria:
  • Patients with acute abdomen with diagnosis other than AP

  • Patients with AP who are under age of 18 years old

  • Patient's refusal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmed Mohammed Abu-Elfatth Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Ahmed M Abu-Elfatth, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Romany Waheed Morkis Beshay, Internal Medicine, Assiut University
ClinicalTrials.gov Identifier:
NCT05859633
Other Study ID Numbers:
  • Romay
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023