The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Accuracy of PSP in diagnosing appendicitis
研究概览
简要总结
PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and the gut. There is evidence from experimental and clinical trials that the levels of PSP in the blood rise in the presence of inflammation or infection. What is not yet well known about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.
详细描述
Interim analysis will be performed once 123 patients are recruited. A power analysis will be performed and the sample size re-calculated based on the actual and precise data collected. At interim analysis, the external data monitoring committee will decide upon the continuation or discontinuation of the trial, as well the potential need to modify the sample size. If any changes are suggested by the external data monitoring committee, the principal investigators will decide on the feasibility of the potential changes and submit a formal addendum to the ethics committee. No changes will be made to the protocol or study design unless first approved by the ethics committee. Any changes to the protocol approved by the ethics committee will be updated at clinicaltrials.gov
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of age (subject to the current ethics approval protocol, may change)
- •Clinical suspicion of appendicitis as the primary or differential diagnoses
- •Patients able to provide informed consent
排除标准
- •Age <18 years of age (subject to the current ethics approval protocol, may change)
- •Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis
- •Pregnancy
- •Patients with impaired consciousness
- •Patients not able to provide informed consent
- •Patients that will receive an appendicectomy as part of another elective procedure
结局指标
主要结局
Accuracy of PSP in diagnosing appendicitis
时间窗: 1 day
ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis
次要结局
- Accuracy of CT in diagnosing appendicitis(1 day)
- Accuracy of the "Alvarado Score" in diagnosis appendicitis(1 day)
- Accuracy of USS in diagnosing appendicitis(1 day)
- Accuracy of CRP in diagnosing appendicitis(1 day)
- Accuracy of WCC in diagnosing appendicitis(1 day)