The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

University of Zurich (UZH)

Status: Unknown

Conditions: Appendicitis; Abdominal Sepsis; Abdominal Pain

Treatments: Procedure: Appendicectomy

Study type: Observational

Funder types: Other

Identifiers

NCT01610193

PSP_Appendix

Details and patient eligibility

About

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.

Full 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

Enrollment: 245 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 1 patient group

Right sided abdominal pain

Description:

Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.

Treatment:

Procedure: Appendicectomy