The Circulating Fibrocyte - a Novel and Accurate Biomarker in Diagnosing Acute Appendicitis in Adults

NCT03988660 | Completed

• 1 other identifier: University of Limerick
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Accurate diagnostic biomarkers for acute appendicitis (AA) are lacking. Circulating fibrocytes (CFs) are increased in inflammatory states. It is not known whether they are altered in appendicitis. This study aimed to assess if CF altered in AA, and compared their diagnostic accuracy with white cell count (WCC), C-reactive protein (CRP), neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils in diagnosis of AA in patients presenting with right iliac fossa pain (RIFP). 95 consecutive adults were recruited in a cohort based prospective study at University Hospital Limerick, 15 were healthy individuals and 80 were patients with RIFP. Peripheral venous samples were obtained at presentation. Clinical, biochemical and histo-pathological parameters were recorded. CF levels were determined by dual-staining for CD45 and Col-1 using FACS and correlated with histopathological diagnoses. P\<0.05 was taken as significant. The study hypothesis is that in patients with suspected appendicitis, CF levels may improve the diagnostics, reduce unnecessary radiation and negative appendicectomy rates.

Conditions

Appendicitis

Keywords

Appendicitis; Fibrocytes; Biomarker

Outcome Measures

Primary Outcomes (3)

• Incidence of patients who have acute appendicitis

  The outcome was assessed by histo-pathology analysis post-operatively

  14 days

• Incidence of normal appendix

  The outcome was assessed by histo-pathology analysis post-operatively

  14 days

• Incidence of patients with alternative diagnosis

  The outcome was assessed clinically following admission

  3 days

Study Arms (4)

Healthy controls

Healthy individuals

Diagnostic Test: Circulating fibrocytes

Histologically confirmed appendicitis

Patients who have diagnosis of appendicitis on histology

Diagnostic Test: Circulating fibrocytes

Histologically normal appendix

Patients who have diagnosis of a normal appendix on histology

Diagnostic Test: Circulating fibrocytes

Alternative diagnosis group

Patients who diagnosed with a condition other than appendicitis

Diagnostic Test: Circulating fibrocytes

Interventions

Circulating fibrocytes DIAGNOSTIC_TEST

Peripheral blood samples were taken from the patients presented with right iliac fossa pain. Samples were collected in sodium heparin (EDTA). Circulating fibrocyte levels were determined by dual staining peripheral blood samples for CD4 and Col-1 using Fluorescence-Activated Cell Sorting (FACS) and correlated with histopathological diagnosis.

Also known as: White Cell Counts, C-reactive protein, Neutrophils, Lymphocytes, Neutrophil-lymphocyte ratio, Monocytes, Basophils and Eosinophils

Alternative diagnosis group; Healthy controls; Histologically confirmed appendicitis; Histologically normal appendix

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individuals and patients presented to the hospital with suspected appendicitis aged 16 year-old- or more.

You may qualify if:

• Any patient presents with right iliac fossa pain
• Age 16 years old or more

You may not qualify if:

• Previous appendicectomy

Sponsors & Collaborators

• University Hospital of Limerick: lead

Study Sites (1)

University Hospital Limerick

Limerick, Ireland

Location

Related Publications (1)

• Zarog M, O'Leary P, Kiernan M, Bolger J, Tibbitts P, Coffey S, Byrnes G, Peirce C, Dunne C, Coffey C. Circulating fibrocyte percentage and neutrophil-lymphocyte ratio are accurate biomarkers of uncomplicated and complicated appendicitis: a prospective cohort study. Int J Surg. 2023 Mar 1;109(3):343-351. doi: 10.1097/JS9.0000000000000234.

  PMID: 37093074 DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Lymphocyte Count

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 17, 2019
• Study Start: June 10, 2015
• Primary Completion: April 14, 2019
• Study Completion: April 14, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

IE (1)