Peri-operative Expression Analysis of Pancreatic Stone Protein in a Surgical Study Population

NCT01258179 | Terminated DMC

• 1 other identifier: 11.2009
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the peri-operative expression of pancreatic stone protein and pancreatitis-associated protein in surgical patients following major abdominal surgery by blood samples.

Conditions

Patients Undergoing Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine

  2 years

Secondary Outcomes (7)

• Intensive Care Unit (ICU) stay in days

  2 years

• hospital stay in days

  2 years

• postoperative complications according to the "Clavien-Dindo Classification" System

  2 years

• hospital costs

  2 years

• comparisons to other known infectious parameters: c-reactive protein (CRP), procalcitonin (PCT), Interleukin 6 (IL-6), Tumor Necrosis Factor Alpha (TNF-alpha), Leucocytes

  2 years

Study Arms (2)

Sepsis Group

Patients suffering from sepsis in the postoperative course after major abdominal surgery

Other: Analysis of PSP and PAP from venous blood samples

Control Group

Patients without suffering sepsis during postoperative follow up after major abdominal surgery

Other: Analysis of PSP and PAP from venous blood samples

Interventions

Analysis of PSP and PAP from venous blood samples OTHER

to analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery

Control Group; Sepsis Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major abdominal surgery

You may qualify if:

• abdominal major surgery
• need for post-operative ICU care

You may not qualify if:

• \- patients who do not agree the written informed consent

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Visceral and Transplantation Surgery

Zurich, CH/Zürich, 8091, Switzerland

Location

Related Publications (2)

• Fisher OM, Raptis DA, Vetter D, Novak A, Dindo D, Hahnloser D, Clavien PA, Nocito A. An outcome and cost analysis of anal fistula plug insertion vs endorectal advancement flap for complex anal fistulae. Colorectal Dis. 2015 Jul;17(7):619-26. doi: 10.1111/codi.12888.

  PMID: 25641401 DERIVED

• Fisher OM, Oberkofler CE, Raptis DA, Soll C, Bechir M, Schiesser M, Graf R. 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). BMJ Open. 2014 Mar 6;4(3):e004914. doi: 10.1136/bmjopen-2014-004914.

  PMID: 24604486 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples

Study Officials

• Christian E Oberkofler, MD

  UniversitaetsSpital Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 10, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

CH (1)