The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain

Conditions
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Appendicitis, Abdominal Pain, Abdominal Sepsis

Intervention / Treatment
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* Procedure: Appendicectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Right sided abdominal pain<br>Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis. | Procedure: Appendicectomy<br>* Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.<br>* Other names: Appendectomy or appendisectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of PSP in diagnosing appendicitis | ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of CRP in diagnosing appendicitis | ROC Curve analysis and predictive value of CRP (C-Reactive Protein) in diagnosing appendicitis | 1 day | 
| Accuracy of WCC in diagnosing appendicitis | ROC Curve analysis and predictive value of WCC (White Cell Count) in diagnosing appendicitis | 1 day | 
| Accuracy of the Alvarado Score in diagnosis appendicitis | ROC Curve analysis and predictive value of Alvarado Score in diagnosing appendicitis | 1 day | 
| Accuracy of USS in diagnosing appendicitis | ROC Curve analysis and predictive value of Ultrasound Scanning (USS) in diagnosing appendicitis, most commonly performed in young females | 1 day | 
| Accuracy of CT in diagnosing appendicitis | ROC Curve analysis and predictive value of CT (Computer Tomography) in diagnosing appendicitis, most commonly performed in the elderly | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Stone Protein, Abdominal pain, Acute appendicitis, Alvarado score, Appendectomy, Sensitivity and specificity