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NCT Number: NCT07793734

CBC-Derived Inflammatory Indices in Acute Pancreatitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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× upper limit of normal, or imaging consistent with acute pancreatitis
  • Admission within 72 hours of symptom onset

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 28-day all-cause mortality

    Time frame: 28 days

    All-cause mortality within 28 days from hospital admission.

  2. Initiation of systemic antibiotics

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

    Proportion of patients receiving systemic antibiotics during the index hospitalization.

  3. Duration of antibiotic therapy

    Time frame: Up to 28 days

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

  4. Infected pancreatic necrosis

    Time frame: Up to 28 days

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

  5. Need for invasive interventions

    Time frame: Up to 28 days

    Requirement for invasive interventions including percutaneous drainage or necrosectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Abanoob M Asham, Resident

CONTACT

[email protected]

01208607107

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prognostic Value of CBC-Derived Immune-Inflammatory Indices for Severity and 28-Day Mortality in Patients With Acute Pancreatitis: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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