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Not yet recruitingNCT07793734Updated Sep 1, 2026

CBC-Derived Inflammatory Indices in Acute Pancreatitis

An observational study in Acute Pancreatitis and Pancreatitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
109
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Acute Pancreatitis
  • Pancreatitis

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Keywords

  • Neutrophil-to-lymphocyte ratio
  • NLR
  • Systemic immune-inflammation index
  • Platelet-to-lymphocyte ratio
  • Prognostic markers
  • SII
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In context

Pancreatitis

557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.

This study's planned enrollment of 109 is below the median of 200 across 192 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with acute pancreatitis admitted to El-Rahgi Liver Hospital, Assiut University, who meet the study eligibility criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of acute pancreatitis based on at least two of the following: characteristic abdominal pain, serum amylase or lipase ≥ 3× , or imaging consistent with acute pancreatitis
  • Admission within 72 hours of symptom onset

Exclusion criteria

Exclusion Criteria:

  • Chronic pancreatitis without an acute episode
  • Severe (neutropenia \< 500/mm³ or high-dose immunosuppressive therapy after solid organ transplantation)
  • Active non-pancreatic infection on admission requiring systemic antibiotics
  • Refusal to provide
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
109 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 28 days

Secondary outcomes

  1. 28-day all-cause mortality

    All-cause mortality within 28 days from hospital admission.

    Time frame: 28 days

  2. Initiation of systemic antibiotics

    Proportion of patients receiving systemic antibiotics during the index hospitalization.

    Time frame: During index hospitalization (up to 28 days)

  3. Duration of antibiotic therapy

    Total number of days of systemic antibiotic therapy during the index hospitalization.

    Time frame: Up to 28 days

  4. Infected pancreatic necrosis

    Occurrence of infected pancreatic necrosis confirmed by microbiological culture or strong clinical and radiological evidence requiring intervention.

    Time frame: Up to 28 days

  5. Need for invasive interventions

    Requirement for invasive interventions including percutaneous drainage or necrosectomy.

    Time frame: Up to 28 days

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Study locations

No study locations are listed for this record.

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References and documents

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 27631223 ↗
  • Zhang 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 34413676 ↗
  • Liu 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 34949937 ↗
  • Salehi 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.

Of 82 non-industry observational studies under Pancreatitis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 133. This study's planned 12 months is below that.

Counting every sponsor, half of 86 studies reached it within 50 months; a quarter within 21 and three quarters within 133.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartEst.
Aug 26, 2026
Primary completionEst.
Aug 26, 2027
CompletionEst.
May 25, 2028
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07793734
Lead sponsor
Assiut University
Responsible party
Abanoob Maged Asham Habib (Resident Physician, Assiut University) — Principal investigator
First posted
Aug 31, 2026
Start date
Aug 26, 2026 (estimated)
Primary completion
Aug 26, 2027 (estimated)
Completion
May 25, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Abanoob M Asham, Resident
Contact
abanob.18313401@med.aun.edu.eg
01208607107
Wael A Abbas, prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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