The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

This study is currently recruiting participants.
Verified August 2013 by University of Zurich
Sponsor:
Collaborators:
Laikon General District Hospital, Athens
University of Athens
Kantonsspital Münsterlingen
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01610193
First received: May 30, 2012
Last updated: August 22, 2013
Last verified: August 2013

May 30, 2012
August 22, 2013
June 2012
December 2013   (final data collection date for primary outcome measure)
Accuracy of PSP in diagnosing appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis
Not Provided
Complete list of historical versions of study NCT01610193 on ClinicalTrials.gov Archive Site
  • Accuracy of CRP in diagnosing appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ROC Curve analysis and predictive value of CRP (C-Reactive Protein) in diagnosing appendicitis
  • Accuracy of WCC in diagnosing appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ROC Curve analysis and predictive value of WCC (White Cell Count) in diagnosing appendicitis
  • Accuracy of the "Alvarado Score" in diagnosis appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ROC Curve analysis and predictive value of Alvarado Score in diagnosing appendicitis
  • Accuracy of USS in diagnosing appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ROC Curve analysis and predictive value of Ultrasound Scanning (USS) in diagnosing appendicitis, most commonly performed in young females
  • Accuracy of CT in diagnosing appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ROC Curve analysis and predictive value of CT (Computer Tomography) in diagnosing appendicitis, most commonly performed in the elderly
Not Provided
Independent predictors of appendicitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Multivariate analysis of to identify independent clinical, laboratory and imaging predictors of appendicitis
Not Provided
 
The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis
The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood and serum or plasma of 245 patients.

Probability Sample

All patients that will present at the emergency department with abdominal pain and a clinical suspicion of acute appendicitis.

  • Appendicitis
  • Abdominal Pain
  • Abdominal Sepsis
Procedure: Appendicectomy
Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.
Other Name: Appendectomy or appendisectomy
Right sided abdominal pain
Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.
Intervention: Procedure: Appendicectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
245
January 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dimitri A Raptis, MD, MSc +41798820542 dimitri.raptis@usz.ch
Contact: Rolf Graf, PhD +41442553041 rolf.graf@usz.ch
Switzerland
 
NCT01610193
PSP_Appendix
Yes
University of Zurich
University of Zurich
  • Laikon General District Hospital, Athens
  • University of Athens
  • Kantonsspital Münsterlingen
Principal Investigator: Dimitri A Raptis, MD, MSc University Hospital Zurich, Department of Surgery
Study Chair: Rolf Graf, PhD University Hospital Zurich, Department of Surgery
University of Zurich
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP