Acute Pancreatitis (AP)NCT07233551
Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.
An observational study of Acute Pancreatitis (AP) and Inflammatory Indices, run by Assiut University.
Trial summary
Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP), Inflammatory Indices
- What is being tested?
- CBC derived inflammatory indices
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- adult patients aged 18 years old or older.
- patients with acute pancreatitis who were treated in our hospital from January 2019 to March 2025.
Who cannot join
- history of chronic kidney disease
- Pregnancy.
- History of neoplasm
- present of acute infection
- history of hematological diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.
Read the 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.
- Conditions
- Acute Pancreatitis (AP), Inflammatory Indices
- Being tested
- CBC derived inflammatory indices
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC derived inflammatory indicesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Prognostic Nutritional Index (PNI) and Clinical Severity of Acute Pancreatitis
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
Measured: Between 48 and 72 hours after hospital admission
Correlation between Systemic Immune-Inflammation Index (SII) and Clinical Severity of Acute Pancreatitis
SII will be calculated as: SII = (Platelet count × Neutrophil count) / Lymphocyte count. The correlation between SII (numeric value) and clinical severity will be assessed.
Measured: Between 48 and 72 hours after hospital admission
Correlation between Systemic Inflammation Response Index (SIRI) and Clinical Severity of Acute Pancreatitis
SIRI will be calculated as: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count. The correlation between SIRI (numeric value) and clinical severity will be assessed.
Measured: Between 48 and 72 hours after hospital admission
Correlation between Platelet-to-Lymphocyte Ratio (PLR) and Clinical Severity of Acute Pancreatitis
PLR will be calculated as: PLR = Platelet count / Lymphocyte count. The correlation between PLR (numeric ratio) and clinical severity will be assessed.
Measured: Between 48 and 72 hours after hospital admission
Correlation between Neutrophil-to-Lymphocyte Ratio (NLR) and Clinical Severity of Acute Pancreatitis
NLR will be calculated as: NLR = Neutrophil count / Lymphocyte count. The correlation between NLR (numeric ratio) and clinical severity will be assessed
Measured: Between 48 and 72 hours after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhameed Ahmed Abdelhameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233551
- Sponsor's protocol ID
- AP Prognosis with IF indices
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu W, Zhang Y, Zhang Y, Qu X, Zhang Z, Zhang R. Association Between the Systemic Inflammation Response Index and Severity of Acute Pancreatitis: A Retrospective Cohort Study. J Inflamm Res. 2025 Mar 27;18:4471-4480. doi: 10.2147/JIR.S512553. eCollection 2025.
PubMed 40166595Alzarea AI, Khan YH, Alanazi AS, Butt MH, Almalki ZS, AlAhmari AK, Alsahali S, Mallhi TH. Barriers and Facilitators of Pharmacoeconomic Studies: A Review of Evidence from the Middle Eastern Countries. Int J Environ Res Public Health. 2022 Jun 27;19(13):7862. doi: 10.3390/ijerph19137862.
PubMed 35805521Mirzaei-Alavijeh M, Amini M, Moradinazar M, Eivazi M, Jalilian F. Disparity in cognitive factors related to cancer screening uptake based on the theory of planned behavior. BMC Cancer. 2024 Jul 16;24(1):845. doi: 10.1186/s12885-024-12607-w.
PubMed 39014335Krinsley JS, Rule P, Pappy L, Ahmed A, Huley-Rodrigues C, Prevedello D, Preiser JC. The Interaction of Acute and Chronic Glycemia on the Relationship of Hyperglycemia, Hypoglycemia, and Glucose Variability to Mortality in the Critically Ill. Crit Care Med. 2020 Dec;48(12):1744-1751. doi: 10.1097/CCM.0000000000004599.
PubMed 33031146Lu Y, Zhang Q, Lou J. Blood glucose-related indicators are associated with in-hospital mortality in critically ill patients with acute pancreatitis. Sci Rep. 2021 Jul 28;11(1):15351. doi: 10.1038/s41598-021-94697-1.
PubMed 34321549Kim Y, Choi H, Jung SM, Song JJ, Park YB, Lee SW. Systemic immune-inflammation index could estimate the cross-sectional high activity and the poor outcomes in immunosuppressive drug-naive patients with antineutrophil cytoplasmic antibody-associated vasculitis. Nephrology (Carlton). 2019 Jul;24(7):711-717. doi: 10.1111/nep.13491. Epub 2019 Apr 29.
PubMed 30203901Liu G, Tao J, Zhu Z, Wang W. The early prognostic value of inflammatory markers in patients with acute pancreatitis. Clin Res Hepatol Gastroenterol. 2019 Jun;43(3):330-337. doi: 10.1016/j.clinre.2018.11.002. Epub 2018 Dec 10.
PubMed 30545732Gorgel SN, Akin Y, Koc EM, Kose O, Ozcan S, Yilmaz Y. Retrospective study of systemic immune-inflammation index in muscle invasive bladder cancer: initial results of single centre. Int Urol Nephrol. 2020 Mar;52(3):469-473. doi: 10.1007/s11255-019-02325-9. Epub 2019 Oct 28.
PubMed 31659597Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
PubMed 30315778
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.
- ClinicalTrials.gov ID
- NCT07233551
- Acronym / sponsor ID
- AP Prognosis with IF indices
- Conditions
- Acute Pancreatitis (AP), Inflammatory Indices
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- adult patients aged 18 years old or older.
- patients with acute pancreatitis who were treated in our hospital from January 2019 to March 2025.
Key exclusion criteria (5 listed)
- history of chronic kidney disease
- Pregnancy.
- History of neoplasm
- present of acute infection
- history of hematological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC derived inflammatory indicesComplete blood count, CBC_based inflammatory indices: 1. Prognostic nutritional index (PNI): PNI is a score based on serum albumin and lymphocyte count, used to assess nutritional and immune status. 2. 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. 3. 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. 4. platelet lymphcyte ratio (PLR) : (PLR) reflects the balance between thrombosis/inflammation (platelets) and immune regulation (lymphocytes). 5. Neutrophile to lymphcyte ratio (NLR) : (NLR) is a widely used inflammatory marker derived from CBC, indicating systemic inflammation and immune response. | Other | – |
Primary outcome
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
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 40166595Wu W, Zhang Y, Zhang Y, Qu X, Zhang Z, Zhang R. Association Between the Systemic Inflammation Response Index and Severity of Acute Pancreatitis: A Retrospective Cohort Study. J Inflamm Res. 2025 Mar 27;18:4471-4480. doi: 10.2147/JIR.S512553. eCollection 2025.
- Background: PubMed 35805521Alzarea AI, Khan YH, Alanazi AS, Butt MH, Almalki ZS, AlAhmari AK, Alsahali S, Mallhi TH. Barriers and Facilitators of Pharmacoeconomic Studies: A Review of Evidence from the Middle Eastern Countries. Int J Environ Res Public Health. 2022 Jun 27;19(13):7862. doi: 10.3390/ijerph19137862.
- Background: PubMed 39014335Mirzaei-Alavijeh M, Amini M, Moradinazar M, Eivazi M, Jalilian F. Disparity in cognitive factors related to cancer screening uptake based on the theory of planned behavior. BMC Cancer. 2024 Jul 16;24(1):845. doi: 10.1186/s12885-024-12607-w.
- Background: PubMed 33031146Krinsley JS, Rule P, Pappy L, Ahmed A, Huley-Rodrigues C, Prevedello D, Preiser JC. The Interaction of Acute and Chronic Glycemia on the Relationship of Hyperglycemia, Hypoglycemia, and Glucose Variability to Mortality in the Critically Ill. Crit Care Med. 2020 Dec;48(12):1744-1751. doi: 10.1097/CCM.0000000000004599.
- Background: PubMed 34321549Lu Y, Zhang Q, Lou J. Blood glucose-related indicators are associated with in-hospital mortality in critically ill patients with acute pancreatitis. Sci Rep. 2021 Jul 28;11(1):15351. doi: 10.1038/s41598-021-94697-1.
- Background: PubMed 30203901Kim Y, Choi H, Jung SM, Song JJ, Park YB, Lee SW. Systemic immune-inflammation index could estimate the cross-sectional high activity and the poor outcomes in immunosuppressive drug-naive patients with antineutrophil cytoplasmic antibody-associated vasculitis. Nephrology (Carlton). 2019 Jul;24(7):711-717. doi: 10.1111/nep.13491. Epub 2019 Apr 29.
- Background: PubMed 30545732Liu G, Tao J, Zhu Z, Wang W. The early prognostic value of inflammatory markers in patients with acute pancreatitis. Clin Res Hepatol Gastroenterol. 2019 Jun;43(3):330-337. doi: 10.1016/j.clinre.2018.11.002. Epub 2018 Dec 10.
- Background: PubMed 31659597Gorgel SN, Akin Y, Koc EM, Kose O, Ozcan S, Yilmaz Y. Retrospective study of systemic immune-inflammation index in muscle invasive bladder cancer: initial results of single centre. Int Urol Nephrol. 2020 Mar;52(3):469-473. doi: 10.1007/s11255-019-02325-9. Epub 2019 Oct 28.
- Background: PubMed 30315778Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis (AP) and Inflammatory Indices, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelhameed Ahmed Abdelhameed, Master Degree (+201158933876, AbdElhamid.17289655@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Prognostic Nutritional Index (PNI) and Clinical Severity of Acute Pancreatitis (time frame: Between 48 and 72 hours after hospital admission). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233551, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.