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.
