The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

• Conditions: Abdominal Pain; Abdominal Sepsis; Appendicitis
• Interventions: Procedure: Appendicectomy

• Registration Number: NCT01610193
• Lead Sponsor: University of Zurich

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-30
• Study Start: 2012-06
• Study First Posted: 2012-06-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Right sided abdominal pain	Appendicectomy	Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.

Primary Outcome Measures

Name	Time	Method
Accuracy of PSP in diagnosing appendicitis	1 day	ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Zurich, Department of Surgery; 🇨🇭 Zurich, Switzerland