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临床试验/NCT03988660
NCT03988660已完成不适用

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

University Hospital of Limerick1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2015年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
1
主要终点
Incidence of patients who have acute appendicitis

研究概览

简要总结

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.

详细描述

Acute appendicitis (AA) is the commonest abdominal emergency. Despite its high prevalence, the diagnosis of appendicitis remains a challenge. The clinical presentation is frequently atypical and symptoms often overlap with many other conditions. Coupled with this, failure to reach a prompt diagnosis can result in adverse outcomes.

Circulating fibrocytes (CFs) were first described in 1994 by Richard Bucala. They are haematopoietic cells derived from the bone marrow. They circulate in the monocyte fraction and can differentiate into myelofibrocytes, fibroblasts and adipocytes (among other cell types). They have a prominent role in inflammatory and healing processes, and in the development of fibrosis.

No studies to date have examined the role of CFs in acute appendicitis. Thus, the aims of this clinical trial were (1) to determine if CFs are altered in acute appendicitis, (2) to assess and compare their diagnostic accuracy with CRP, WCC, neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils, and (3) to determine the most reliable predictors in diagnosing AA.

A prospective cohort study was undertaken to (1) determine circulating fibrocytes levels (CF) in patients with histologically confirmed acute appendicitis (AA), and (2) to determine the sensitivity and specificity of circulating CF levels in the diagnosis of AA, in adults (age ≥ 16 years) presenting acutely with right iliac fossa pain, at the University hospital Limerick. The diagnosis of appendicitis was confirmed by histopathological assessment following appendicectomy.

Patients were divided in three cohorts following their final diagnosis on discharge and based on the histopathology results. (1) patients with RIFP who underwent an appendicectomy and had a normal appendix at histological assessment i.e histologically proven normal appendix group (HPNG). (2) patients with RIFP who underwent an appendicectomy and had an inflamed appendix at histological assessment i.e histologically proven appendicitis group (HPAG). (3) patients with RIFP who had an alternate diagnosis on discharge other than appendicitis i.e alternative diagnosis group (ADG). Another cohort was added as (4) healthy controls.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Previous appendicectomy

结局指标

主要结局

Incidence of patients who have acute appendicitis

时间窗: 14 days

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

Incidence of normal appendix

时间窗: 14 days

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

Incidence of patients with alternative diagnosis

时间窗: 3 days

The outcome was assessed clinically following admission

次要结局

未报告次要终点

研究者

发起方
University Hospital of Limerick
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Zarog

Principal Investigator

University Hospital of Limerick

研究点 (1)

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