NCT07793734

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Aug 2026May 2028

First Submitted

Initial submission to the registry

August 26, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2028

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 26, 2026

Last Update Submit

August 28, 2026

Conditions

Acute PancreatitisPancreatitis

Keywords

Neutrophil-to-lymphocyte ratioNLRSystemic immune-inflammation indexPlatelet-to-lymphocyte ratioPrognostic markersSII

Outcome Measures

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)

    Up to 28 days

Secondary Outcomes (5)

  • 28-day all-cause mortality

    28 days

  • Initiation of systemic antibiotics

    During index hospitalization (up to 28 days)

  • Duration of antibiotic therapy

    Up to 28 days

  • Infected pancreatic necrosis

    Up to 28 days

  • Need for invasive interventions

    Up to 28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 27631223BACKGROUND

  • 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.

    PMID: 34413676BACKGROUND

  • 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.

    PMID: 34949937BACKGROUND

  • 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.

    PMID: 41126061BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Wael A Abbas, prof

    Internal Medicine Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Abanoob M Asham, Resident

CONTACT

01208607107abanob.18313401@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

August 26, 2026

Primary Completion (Estimated)

August 26, 2027

Study Completion (Estimated)

May 25, 2028

Last Updated

September 1, 2026

Record last verified: 2026-08