The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Appendicitis
Abdominal Pain
Abdominal Sepsis
Procedure: Appendicectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

Whole blood and serum or plasma of 245 patients.


Estimated Enrollment: 245
Study Start Date: June 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Appendectomy or appendisectomy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610193

Contacts
Contact: Dimitri A Raptis, MD, MSc +41798820542 dimitri.raptis@usz.ch
Contact: Rolf Graf, PhD +41442553041 rolf.graf@usz.ch

Locations
Switzerland
University Hospital Zurich, Department of Surgery Not yet recruiting
Zurich, Switzerland, CH-8091
Contact: Dimitri A Raptis, MD, MSc    +41798820542    dimitri.raptis@usz.ch   
Contact: Rolf Graf, PhD    +41442553041    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         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Dimitri A Raptis, MD, MSc    +41798820542    dimitri.raptis@usz.ch   
Contact: Rolf Graf, PhD       rolf.graf@usz.ch   
Principal Investigator: Dimitri A Raptis, MD, MSc         
Principal Investigator: Rolf Graf, PhD         
Sponsors and Collaborators
University of Zurich
Laikon General District Hospital, Athens
University of 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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01610193     History of Changes
Other Study ID Numbers: PSP_Appendix
Study First Received: May 30, 2012
Last Updated: August 22, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Pancreatic Stone Protein
Abdominal pain
Acute appendicitis
Alvarado score
Appendectomy
Sensitivity and specificity

Additional relevant MeSH terms:
Appendicitis
Abdominal Pain
Acute Disease
Sepsis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 28, 2014