title: Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP): a protocol of a cohort study on the diagnostic efficacy and prognostic value of PSP and PAP as postoperative markers of septic complications in patients undergoing abdominal surgery (PSP study).
abstract: BACKGROUND
  Major abdominal surgery leads to a postoperative systemic inflammatory response, making it difficult to discriminate patients with systemic inflammatory response syndrome from those with a beginning postoperative infectious complication. At present, physicians have to rely on their clinical experience to differentiate between the two. Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP), both secretory proteins produced by the pancreas, are dramatically increased during pancreatic disease and have been shown to act as acute-phase proteins. Increased levels of PSP have been detected in polytrauma patients developing sepsis and PSP has shown a high diagnostic accuracy in discriminating the severity of peritonitis and in predicting death in intensive care unit patients. However, the prognostic value of PSP/PAP for infectious complications among patients undergoing major abdominal surgery is unknown.
  
  
  METHODS
  160 patients undergoing major abdominal surgery will be recruited preoperatively. On the day before surgery, baseline blood values are attained. Following surgery, daily blood samples for measuring regular inflammatory markers (c-reactive protein, procalcitonin, interleukin-6, tumour necrosis factor-α and leucocyte counts) and PSP/PAP will be acquired. PSP/PAP will be measured using a validated ELISA developed in our research laboratory. Patient's discharge marks the end of his/her trial participation. Complication grade including mortality and occurrence of infectious postoperative complications according to validated diagnostic criteria will be correlated with PSP/PAP values. Total intensive care unit days and total length of stay will be recorded as further outcome parameters.
  
  
  BACKGROUND
  The PSP trial is a prospective monocentric cohort study evaluating the prognostic value of PSP and PAP for postoperative infectious complications. In addition, a comparison with established inflammatory markers in patients undergoing major abdominal surgery will be performed to help evaluate the role of these proteins in predicting and diagnosing infectious and other postoperative complications.
  KEKZH-Nr. STV 11-2009.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01258179.
authors.affiliation: Department of Surgery, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Oliver Maximilian
authors.initials: OM
authors.lastname: Fisher
authors.forename: Christian Eugen
authors.initials: CE
authors.lastname: Oberkofler
authors.forename: Dimitri Aristotle
authors.initials: DA
authors.lastname: Raptis
authors.forename: Christopher
authors.initials: C
authors.lastname: Soll
authors.forename: Markus
authors.initials: M
authors.lastname: Béchir
authors.forename: Marc
authors.initials: M
authors.lastname: Schiesser
authors.forename: Rolf
authors.initials: R
authors.lastname: Graf
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000951:Antigens, Neoplasm / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D014408:Biomarkers, Tumor / Q000097:blood*; D003937:Diagnosis, Differential; D006801:Humans; D037181:Lectins, C-Type / Q000097:blood*; D051847:Lithostathine / Q000097:blood*; D000073718:Pancreatitis-Associated Proteins; D011183:Postoperative Complications / Q000175:diagnosis*; D011446:Prospective Studies; D018805:Sepsis / Q000175:diagnosis*; D018746:Systemic Inflammatory Response Syndrome / Q000175:diagnosis
chemical_list: D000951:Antigens, Neoplasm; D015415:Biomarkers; D014408:Biomarkers, Tumor; D037181:Lectins, C-Type; D051847:Lithostathine; D000073718:Pancreatitis-Associated Proteins; C497617:REG1A protein, human; C000612141:REG3A protein, human