Patients Undergoing Major Abdominal SurgeryNCT01258179
Peri-operative Expression Analysis of Pancreatic Stone Protein in a Surgical Study Population
An observational study of Patients Undergoing Major Abdominal Surgery, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patients Undergoing Major Abdominal Surgery
- What is being tested?
- Analysis of PSP and PAP from venous blood samples
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major abdominal surgery
Who may be able to join
- abdominal major surgery
- need for post-operative ICU care
Who cannot join
- patients who do not agree the written informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral and Transplantation Surgery
Zurich, CH/Zürich, 8091
About this study
Official title: Peri-operative Expression Analysis of Pancreatic Stone Protein and Pancreatitis-associated Protein in a Surgical Study Population
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.
- Being tested
- Analysis of PSP and PAP from venous blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of PSP and PAP from venous blood samplesOther
to analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Group | Patients suffering from sepsis in the postoperative course after major abdominal surgery Receives: Other: Analysis of PSP and PAP from venous blood samples | |
| Control Group | Patients without suffering sepsis during postoperative follow up after major abdominal surgery Receives: Other: Analysis of PSP and PAP from venous blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine
Measured: 2 years
Secondary outcomes (7)
Intensive Care Unit (ICU) stay in days
Measured: 2 years
hospital stay in days
Measured: 2 years
postoperative complications according to the "Clavien-Dindo Classification" System
Measured: 2 years
hospital costs
Measured: 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
Measured: 2 years
Bacteriaemia in the blood
Measured: 2 years
Platelets in the blood
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian E Oberkofler, MD, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258179
- Sponsor's protocol ID
- 11.2009
- Status last verified
- May 2018
- First submitted
- 7 Dec 2010
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 25641401Fisher 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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Expression Analysis of Pancreatic Stone Protein and Pancreatitis-associated Protein in a Surgical Study Population
- ClinicalTrials.gov ID
- NCT01258179
- Acronym / sponsor ID
- 11.2009
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis Group | – | Other: Analysis of PSP and PAP from venous blood samplesPatients suffering from sepsis in the postoperative course after major abdominal surgery |
| Control Group | – | Other: Analysis of PSP and PAP from venous blood samplesPatients without suffering sepsis during postoperative follow up after major abdominal surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major abdominal surgery
Key inclusion criteria (2 listed)
- abdominal major surgery
- need for post-operative ICU care
Key exclusion criteria (1 listed)
- patients who do not agree the written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of PSP and PAP from venous blood samplesto analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery | Other | Control Group, Sepsis Group |
Primary outcome
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
7 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
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 25641401Fisher 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.
- Derived from this study: PubMed 24604486Fisher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian E Oberkofler, MD principal investigator
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Major Abdominal Surgery, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258179, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.