Acute PancreatitisNCT07793734
CBC-Derived Inflammatory Indices in Acute Pancreatitis
An observational study of Acute Pancreatitis and Pancreatitis, run by Assiut University.
Trial summary
This prospective observational study aims to evaluate the prognostic value of complete blood count (CBC)-derived inflammatory indices, including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII), for predicting severe acute pancreatitis and 28-day… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Pancreatitis
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2026to 25 May 2028
- How long will I take part?
- 28 Days
- 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: Adult patients with acute pancreatitis admitted to El-Rahgi Liver Hospital, Assiut University, who meet the study eligibility criteria.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of acute pancreatitis based on at least two of the following: characteristic abdominal pain, serum amylase or lipase ≥ 3× upper limit of normal, or imaging consistent with acute pancreatitis
- Admission within 72 hours of symptom onset
Who cannot join
- Chronic pancreatitis without an acute episode
- Severe immunosuppression (neutropenia < 500/mm³ or high-dose immunosuppressive therapy after solid organ transplantation)
- Active non-pancreatic infection on admission requiring systemic antibiotics
- Refusal to provide informed consent
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
Official title: Prognostic Value of CBC-Derived Immune-Inflammatory Indices for Severity and 28-Day Mortality in Patients With Acute Pancreatitis: A Prospective Observational Study
This prospective observational study aims to evaluate the prognostic value of complete blood count (CBC)-derived inflammatory indices, including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII), for predicting severe acute pancreatitis and 28-day mortality in adult patients admitted with acute pancreatitis.
Read the detailed description
Acute pancreatitis (AP) ranges from mild self-limiting disease to severe forms associated with persistent organ failure, infected necrosis, and substantial mortality. Early identification of patients at high risk of severe disease is essential for appropriate triage and management.
CBC-derived inflammatory indices such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) are inexpensive and widely available markers that have demonstrated prognostic value in critical illness. Their specific role in predicting severity and mortality in acute pancreatitis requires further evaluation.
This prospective observational study will assess admission and early serial CBC-derived indices as predictors of severe acute pancreatitis (defined by the revised Atlanta criteria) and 28-day all-cause mortality, and will compare their predictive performance with standard clinical severity scores including APACHE II and BISAP.
- Conditions
- Acute Pancreatitis, Pancreatitis
- Keywords
- Neutrophil-to-lymphocyte ratio, NLR, Systemic immune-inflammation index, Platelet-to-lymphocyte ratio, Prognostic markers, SII
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe acute pancreatitis
Occurrence of severe acute pancreatitis defined as persistent organ failure lasting more than 48 hours according to the revised Atlanta criteria (using Marshall or SOFA score thresholds)
Measured: Up to 28 days
Secondary outcomes (5)
28-day all-cause mortality
All-cause mortality within 28 days from hospital admission.
Measured: 28 days
Initiation of systemic antibiotics
Proportion of patients receiving systemic antibiotics during the index hospitalization.
Measured: During index hospitalization (up to 28 days)
Duration of antibiotic therapy
Total number of days of systemic antibiotic therapy during the index hospitalization.
Measured: Up to 28 days
Infected pancreatic necrosis
Occurrence of infected pancreatic necrosis confirmed by microbiological culture or strong clinical and radiological evidence requiring intervention.
Measured: Up to 28 days
Need for invasive interventions
Requirement for invasive interventions including percutaneous drainage or necrosectomy.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start26 Aug 2026 (estimated)
- Primary completion26 Aug 2027 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies 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
- Prospective
- Enrolment
- 109 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoob Maged Asham Habib, Assiut University
- Investigators
- Wael A Abbas, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793734
- Sponsor's protocol ID
- AP-CBC-Indices-2026
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Wu W, Dong L, Yang C, Fan P, Wu H. Neutrophil to lymphocyte ratio predicts persistent organ failure and in-hospital mortality in an Asian Chinese population of acute pancreatitis. Medicine (Baltimore). 2016 Sep;95(37):e4746. doi: 10.1097/MD.0000000000004746.
PubMed 27631223Zhang D, Wang T, Dong X, Sun L, Wu Q, Liu J, Sun X. Systemic Immune-Inflammation Index for Predicting the Prognosis of Critically Ill Patients with Acute Pancreatitis. Int J Gen Med. 2021 Aug 13;14:4491-4498. doi: 10.2147/IJGM.S314393. eCollection 2021.
PubMed 34413676Liu X, Guan G, Cui X, Liu Y, Liu Y, Luo F. Systemic Immune-Inflammation Index (SII) Can Be an Early Indicator for Predicting the Severity of Acute Pancreatitis: A Retrospective Study. Int J Gen Med. 2021 Dec 8;14:9483-9489. doi: 10.2147/IJGM.S343110. eCollection 2021.
PubMed 34949937Salehi AM, Rezaei R, Sadeghi A, Ayubi E, Hasanzarrini M, Azandaryani AR, Razzaghi M. Diagnostic value of neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune-inflammation index for predicting the severity of acute pancreatitis. BMC Gastroenterol. 2025 Oct 22;25(1):751. doi: 10.1186/s12876-025-04370-4.
PubMed 41126061
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of CBC-Derived Immune-Inflammatory Indices for Severity and 28-Day Mortality in Patients With Acute Pancreatitis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07793734
- Acronym / sponsor ID
- AP-CBC-Indices-2026
- Conditions
- Acute Pancreatitis, Pancreatitis
- Keywords
- Neutrophil-to-lymphocyte ratio, NLR, Systemic immune-inflammation index, Platelet-to-lymphocyte ratio, Prognostic markers, SII
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Aug 2026 (estimated)
- Primary completion
- 26 Aug 2027 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 31 Aug 2026 (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.
This prospective observational study aims to evaluate the prognostic value of complete blood count (CBC)-derived inflammatory indices, including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII), for predicting severe acute pancreatitis and 28-day mortality in adult patients admitted with acute pancreatitis.
Detailed description
Acute pancreatitis (AP) ranges from mild self-limiting disease to severe forms associated with persistent organ failure, infected necrosis, and substantial mortality. Early identification of patients at high risk of severe disease is essential for appropriate triage and management.
CBC-derived inflammatory indices such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) are inexpensive and widely available markers that have demonstrated prognostic value in critical illness. Their specific role in predicting severity and mortality in acute pancreatitis requires further evaluation.
This prospective observational study will assess admission and early serial CBC-derived indices as predictors of severe acute pancreatitis (defined by the revised Atlanta criteria) and 28-day all-cause mortality, and will compare their predictive performance with standard clinical severity scores including APACHE II and BISAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acute pancreatitis admitted to El-Rahgi Liver Hospital, Assiut University, who meet the study eligibility criteria.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Diagnosis of acute pancreatitis based on at least two of the following: characteristic abdominal pain, serum amylase or lipase ≥ 3× upper limit of normal, or imaging consistent with acute pancreatitis
- Admission within 72 hours of symptom onset
Key exclusion criteria (4 listed)
- Chronic pancreatitis without an acute episode
- Severe immunosuppression (neutropenia < 500/mm³ or high-dose immunosuppressive therapy after solid organ transplantation)
- Active non-pancreatic infection on admission requiring systemic antibiotics
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe acute pancreatitis
Time frame: Up to 28 days
Occurrence of severe acute pancreatitis defined as persistent organ failure lasting more than 48 hours according to the revised Atlanta criteria (using Marshall or SOFA score thresholds)
5 secondary outcomes
28-day all-cause mortality
Time frame: 28 days
Initiation of systemic antibiotics
Time frame: During index hospitalization (up to 28 days)
Duration of antibiotic therapy
Time frame: Up to 28 days
Infected pancreatic necrosis
Time frame: Up to 28 days
Need for invasive interventions
Time frame: Up to 28 days
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 1 Sep 2026.
- Background: PubMed 27631223Zhang Y, Wu W, Dong L, Yang C, Fan P, Wu H. Neutrophil to lymphocyte ratio predicts persistent organ failure and in-hospital mortality in an Asian Chinese population of acute pancreatitis. Medicine (Baltimore). 2016 Sep;95(37):e4746. doi: 10.1097/MD.0000000000004746.
- Background: PubMed 34413676Zhang D, Wang T, Dong X, Sun L, Wu Q, Liu J, Sun X. Systemic Immune-Inflammation Index for Predicting the Prognosis of Critically Ill Patients with Acute Pancreatitis. Int J Gen Med. 2021 Aug 13;14:4491-4498. doi: 10.2147/IJGM.S314393. eCollection 2021.
- Background: PubMed 34949937Liu X, Guan G, Cui X, Liu Y, Liu Y, Luo F. Systemic Immune-Inflammation Index (SII) Can Be an Early Indicator for Predicting the Severity of Acute Pancreatitis: A Retrospective Study. Int J Gen Med. 2021 Dec 8;14:9483-9489. doi: 10.2147/IJGM.S343110. eCollection 2021.
- Background: PubMed 41126061Salehi AM, Rezaei R, Sadeghi A, Ayubi E, Hasanzarrini M, Azandaryani AR, Razzaghi M. Diagnostic value of neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune-inflammation index for predicting the severity of acute pancreatitis. BMC Gastroenterol. 2025 Oct 22;25(1):751. doi: 10.1186/s12876-025-04370-4.
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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.
Wael A Abbas, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis and Pancreatitis, 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 3 inclusion and 4 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 1 Sep 2026. 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 Abanoob M Asham, Resident (01208607107, abanob.18313401@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe acute pancreatitis (time frame: Up to 28 days). 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 NCT07793734, which also lists 4 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 1 Sep 2026.