TerminatedNCT01258179Updated May 17, 2018

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

An observational study in Patients Undergoing Major Abdominal Surgery, sponsored by University of Zurich. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by University of Zurich · Observational

Why this study was terminated

low recruitment

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 30
Ages: 18 Years to 99 Years
Sex: All

Study 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 studied

Patients Undergoing Major Abdominal Surgery

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 132 are open to participants now.

Browse University of Zurich studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients undergoing major abdominal surgery

Eligibility criteria

Inclusion criteria: - >= 18 years

abdominal major surgery
need for post-operative ICU care

Exclusion criteria: - \<18 years

- patients who do not agree the written informed consent

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 30 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

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

OtherAnalysis of PSP and PAP from venous blood samples
to analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery

What researchers measure

Primary outcomes

Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine
Time frame: 2 years

Secondary outcomes

Intensive Care Unit (ICU) stay in days
Time frame: 2 years
hospital stay in days
Time frame: 2 years
postoperative complications according to the "Clavien-Dindo Classification" System
Time frame: 2 years
hospital costs
Time frame: 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
Time frame: 2 years
Bacteriaemia in the blood
Time frame: 2 years
Platelets in the blood
Time frame: 2 years

Study locations

1 site

Department of Visceral and Transplantation Surgery
Zurich, CH/Zürich 8091, Switzerland

References and documents

Publications

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. PubMed 25641401 ↗
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. PubMed 24604486 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01258179
Lead sponsor: University of Zurich
Responsible party: Sponsor
First posted: Dec 10, 2010
Start date: Feb 2011
Primary completion: Dec 2017
Completion: Dec 2017
Last update: May 17, 2018

Study contacts

Christian E Oberkofler, MD

principal investigator · UniversitaetsSpital Zuerich

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Zurich →

Start the discussion