Clinical trial NCT01610193: The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis
Official title: The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appendicitis
Abdominal Pain
Abdominal Sepsis
Keywords: Pancreatic Stone Protein
Abdominal pain
Acute appendicitis
Alvarado score
Appendectomy
Sensitivity and specificity
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Laikο General Hospital, Athens
name: University of Athens
name: Kantonsspital Münsterlingen
First posted: 2012-06-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of PSP in diagnosing appendicitis
timeFrame: 1 day
Secondary outcomes:
measure: Accuracy of CRP in diagnosing appendicitis
timeFrame: 1 day
measure: Accuracy of WCC in diagnosing appendicitis
timeFrame: 1 day
measure: Accuracy of the "Alvarado Score" in diagnosis appendicitis
timeFrame: 1 day
measure: Accuracy of USS in diagnosing appendicitis
timeFrame: 1 day
measure: Accuracy of CT in diagnosing appendicitis
timeFrame: 1 day
Other outcomes:
measure: Independent predictors of appendicitis
timeFrame: 1 day
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Surgery
Study officials:
affiliation: University Hospital Zurich, Department of Surgery
name: Dimitri A Raptis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Surgery
name: Rolf Graf, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.
citation: 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.
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. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
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. doi: 10.1074/jbc.272.5.3073.
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 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.
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. doi: 10.2169/internalmedicine.50.5362. Epub 2011 Aug 1.
citation: 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.