The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01610193
• Other study ID #: PSP_Appendix
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2012
• Last updated: August 22, 2013
• Start date: June 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2013
• Source: University of Zurich
• Contact: Dimitri A Raptis, MD, MSc
• Phone: +41798820542
• Email: dimitri.raptis[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Pain
• Abdominal Sepsis
• Acute Disease
• Appendicitis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich
Switzerland	University Hospital Zurich, Department of Surgery	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Kantonsspital Münsterlingen, Laikon General District Hospital, Athens, University of Athens

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. — View Citation

Bimmler D, Graf R, Scheele GA, Frick TW. Pancreatic stone protein (lithostathine), a physiologically relevant pancreatic calcium carbonate crystal inhibitor? J Biol Chem. 1997 Jan 31;272(5):3073-82. — View Citation

Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-32. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation

Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. Epub 2005 Dec 19. Review. — View Citation

Jin CX, Hayakawa T, Ko SB, Ishiguro H, Kitagawa M. Pancreatic stone protein/regenerating protein family in pancreatic and gastrointestinal diseases. Intern Med. 2011;50(15):1507-16. Epub 2011 Aug 1. Review. — View Citation

Keel M, Härter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6. — View Citation

Planas R, Pujol-Autonell I, Ruiz E, Montraveta M, Cabre E, Lucas-Martin A, Pujol-Borrell R, Martinez-Caceres E, Vives-Pi M. Regenerating gene Ia is a biomarker for diagnosis and monitoring of celiac disease: a preliminary study. Transl Res. 2011 Sep;158(3):140-5. doi: 10.1016/j.trsl.2011.04.004. Epub 2011 May 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Independent predictors of appendicitis	Multivariate analysis of to identify independent clinical, laboratory and imaging predictors of appendicitis	1 day	No
Primary	Accuracy of PSP in diagnosing appendicitis	ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis	1 day	No
Secondary	Accuracy of CRP in diagnosing appendicitis	ROC Curve analysis and predictive value of CRP (C-Reactive Protein) in diagnosing appendicitis	1 day	No
Secondary	Accuracy of WCC in diagnosing appendicitis	ROC Curve analysis and predictive value of WCC (White Cell Count) in diagnosing appendicitis	1 day	No
Secondary	Accuracy of the "Alvarado Score" in diagnosis appendicitis	ROC Curve analysis and predictive value of Alvarado Score in diagnosing appendicitis	1 day	No
Secondary	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	No
Secondary	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	No

External Links

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