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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05859633
Other study ID # Romay
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2023
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Assiut University
Contact Ahmed M Abu-Elfatth
Phone +18677791
Email ahmed111@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Ahmed Mohammed Abu-Elfatth Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317. Erratum In: JAMA. 2021 Jun 15;325(23):2405. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary severe acute pancreatitis frequency of severe acute pancreatitis one year
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