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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Pain; Appendicitis; Abdominal Sepsis
• Intervention / Treatment: Procedure: Appendicectomy

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 Type: Observational
• Enrollment (Anticipated): 245

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Dimitri A Raptis, MD, MSc; Phone Number: +41798820542; Email: dimitri.raptis@usz.ch
    • Contact: Rolf Graf, PhD; Email: rolf.graf@usz.ch
    • Principal Investigator: Dimitri A Raptis, MD, MSc
    • Principal Investigator: Rolf Graf, PhD
  • Zurich, Switzerland, CH-8091
    • Not yet recruiting
    • University Hospital Zurich, Department of Surgery
    • Contact: Dimitri A Raptis, MD, MSc; Phone Number: +41798820542; Email: dimitri.raptis@usz.ch
    • Contact: Rolf Graf, PhD; Phone Number: +41442553041; Email: rolf.graf@usz.ch
    • Principal Investigator: Dimitri A Raptis, MD, MSc
    • Principal Investigator: Rolf Graf, PhD
    • Sub-Investigator: Christoph Tschuor, MD
    • Sub-Investigator: Christian E Oberkofler, MD
    • Sub-Investigator: Stefan Breitenstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right sided abdominal pain; Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.	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 Names: Appendectomy or appendisectomy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent predictors of appendicitis	Multivariate analysis of to identify independent clinical, laboratory and imaging predictors of appendicitis	1 day

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University of Athens; Laikο General Hospital, Athens; Kantonsspital Münsterlingen
• Investigators: Principal Investigator: Dimitri A Raptis, MD, MSc, University Hospital Zurich, Department of Surgery; Study Chair: Rolf Graf, PhD, University Hospital Zurich, Department of Surgery

Publications and helpful links

General Publications

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes 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.
• Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.
• 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):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.
• Keel M, Harter 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.
• 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. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
• 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. doi: 10.1074/jbc.272.5.3073.
• 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 Ialpha 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.
• 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. doi: 10.2169/internalmedicine.50.5362. Epub 2011 Aug 1.
• Tschuor C, Raptis DA, Limani P, Bachler T, Oberkofler CE, Breitenstein S, Graf R. The value of pancreatic stone protein in predicting acute appendicitis in patients presenting at the emergency department with abdominal pain. BMC Gastroenterol. 2012 Oct 25;12:154. doi: 10.1186/1471-230X-12-154.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 30, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Sensitivity and specificity; Abdominal pain; Appendectomy; Acute appendicitis; Pancreatic Stone Protein; Alvarado score
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Abdominal Pain; Appendicitis
• Other Study ID Numbers: PSP_Appendix