Postoperative ComplicationsNCT04294797
Presepsin as a Predictor for Postoperative Complications Following Pancreatic Resection
A study testing Blood draw in people with Postoperative Complications, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The study investigates the local and systemic inflammatory response following pancreatic resections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Blood draw
- How many people
- 86 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jul 2017to 31 Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any pancreatic pathology (benign and malign) requiring surgery
- Written informed consent
- >= 18 years
Who cannot join
- Pregnancy
- Patients who are not capable of giving informed consent (e.g. with existing medical trustee)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilotstudie: Presepsin Als möglicher Prädiktor Postoperativer Komplikationen Nach Pankreasresektionen
The study investigates the local and systemic inflammatory response following pancreatic resections.
Read the detailed description
Pancreatic resections (PR) are major hepato-pancreatico-biliary (HPB) surgeries associated with significant morbidity and mortality. Despite improvements in surgical technique, as well as peri- and postoperative care, mortality rates range from 2-5%, even in high volume centres. Moreover, morbidity rates after PR can be as high as 70%, especially when evaluated in a prospective setting. In this context, postoperative pancreatic fistula (POPF) represents one of the most frequent complications following PR, with a high variability in the literature ranging from 20% to 64%. Besides POPF, the most frequent complications following PR are delayed gastric emptying (DGE, 18%), postoperative fluid collections (10%), postoperative haemorrhage (PPH, 10%), wound infections (10%), or intra-abdominal abscesses (5%). All of these complications are often characterized by infection and sepsis, and despite all intensive-medical measures, associated with high mortality. In this context, early anticipation and appropriate treatment of clinically relevant grade B or C POPF (CR-POPF) is of utmost importance to prevent fatal outcome.
In order to aid with timely detection and therapy of potentially severe POPF, evaluation of predictive biomarkers that could be able to differentiate early between non-significant biochemical leaks and potentially severe CR-POPF is of urgent interest for all specialties involved in the treatment of pancreatic surgery patients.
Over the last decade, various biomarkers have already been assessed: Procalcitonin (PCT) is one of the most frequently used markers. It has advantages over common infection parameters such as CRP or white blood cells but is often altered in various forms of systemic inflammation and thus not precise enough for an accurate clinical assessment. Connor et al. proposed, that the early postoperative local inflammatory process (postoperative acute pancreatitis, POAP) represents one of the main determinants in POPF development and systemic response measured by CRP could predict severity of POPF. Moreover, in the LEOPARD-2 trial, higher postoperative IL-6 levels were found in patients with severe complications including CR-POPF, whereas IL-8 and CRP Levels in their series were comparable between groups.
More recently, also Presepsin (soluble CD14) showed promising results as a biomarker for sepsis diagnosis and postoperative complications but has never been assessed in the context of major HPB surgeries.
Early detection and therapy of potentially life-threatening complications following major HPB surgery is of urgent interest for all specialties involved in the treatment of these patients and studies investigating the predictive value of Presepsin and other inflammatory markers following PR are lacking. Accordingly, the aim of the present pilot study is to evaluate, for the first time, the kinetics of the biomarker Presepsin after PR and to predict the clinical course.
- Conditions
- Postoperative Complications
- Being tested
- Blood draw
- Keywords
- Pancreatic resection, POPF, Inflammatory response
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
One additional blood sample for study purpose from the day before surgery, postoperative 1, 3 and 8.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presepsin
Correlation of Presespin values with postoperative complications, especially POPF.
Measured: Preoperative until postoperative day 8.
Secondary outcomes (1)
Biomarker assessment
Correlation of different biomarkers (CRP, IL-1, IL-6, IL-8, Procalcitonin) with operation associated postoperative complications after pancreatic resections.
Measured: Preoperative until postoperative day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start11 Jul 2017
- Primary completion26 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294797
- Sponsor's protocol ID
- Presepsin
- Status last verified
- Feb 2020
- First submitted
- 2 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gasteiger S, Primavesi F, Gobel G, Braunwarth E, Cardini B, Maglione M, Sopper S, Ofner D, Stattner S. Early Post-Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL-6 Predict Pancreatic Fistula. World J Surg. 2020 Dec;44(12):4236-4244. doi: 10.1007/s00268-020-05768-9. Epub 2020 Sep 8.
PubMed 32901324
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilotstudie: Presepsin Als möglicher Prädiktor Postoperativer Komplikationen Nach Pankreasresektionen
- ClinicalTrials.gov ID
- NCT04294797
- Acronym / sponsor ID
- Presepsin
- Conditions
- Postoperative Complications
- Keywords
- Pancreatic resection, POPF, Inflammatory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Mar 2020 (actual)
- 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 study investigates the local and systemic inflammatory response following pancreatic resections.
Detailed description
Pancreatic resections (PR) are major hepato-pancreatico-biliary (HPB) surgeries associated with significant morbidity and mortality. Despite improvements in surgical technique, as well as peri- and postoperative care, mortality rates range from 2-5%, even in high volume centres. Moreover, morbidity rates after PR can be as high as 70%, especially when evaluated in a prospective setting. In this context, postoperative pancreatic fistula (POPF) represents one of the most frequent complications following PR, with a high variability in the literature ranging from 20% to 64%. Besides POPF, the most frequent complications following PR are delayed gastric emptying (DGE, 18%), postoperative fluid collections (10%), postoperative haemorrhage (PPH, 10%), wound infections (10%), or intra-abdominal abscesses (5%). All of these complications are often characterized by infection and sepsis, and despite all intensive-medical measures, associated with high mortality. In this context, early anticipation and appropriate treatment of clinically relevant grade B or C POPF (CR-POPF) is of utmost importance to prevent fatal outcome.
In order to aid with timely detection and therapy of potentially severe POPF, evaluation of predictive biomarkers that could be able to differentiate early between non-significant biochemical leaks and potentially severe CR-POPF is of urgent interest for all specialties involved in the treatment of pancreatic surgery patients.
Over the last decade, various biomarkers have already been assessed: Procalcitonin (PCT) is one of the most frequently used markers. It has advantages over common infection parameters such as CRP or white blood cells but is often altered in various forms of systemic inflammation and thus not precise enough for an accurate clinical assessment. Connor et al. proposed, that the early postoperative local inflammatory process (postoperative acute pancreatitis, POAP) represents one of the main determinants in POPF development and systemic response measured by CRP could predict severity of POPF. Moreover, in the LEOPARD-2 trial, higher postoperative IL-6 levels were found in patients with severe complications including CR-POPF, whereas IL-8 and CRP Levels in their series were comparable between groups.
More recently, also Presepsin (soluble CD14) showed promising results as a biomarker for sepsis diagnosis and postoperative complications but has never been assessed in the context of major HPB surgeries.
Early detection and therapy of potentially life-threatening complications following major HPB surgery is of urgent interest for all specialties involved in the treatment of these patients and studies investigating the predictive value of Presepsin and other inflammatory markers following PR are lacking. Accordingly, the aim of the present pilot study is to evaluate, for the first time, the kinetics of the biomarker Presepsin after PR and to predict the clinical course.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with any pancreatic pathology (benign and malign) requiring surgery
- Written informed consent
- >= 18 years
Key exclusion criteria (2 listed)
- Pregnancy
- Patients who are not capable of giving informed consent (e.g. with existing medical trustee)
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 |
|---|---|---|
| Blood drawOne additional blood sample for study purpose from the day before surgery, postoperative 1, 3 and 8. | Diagnostic test | – |
Primary outcome
Presepsin
Time frame: Preoperative until postoperative day 8.
Correlation of Presespin values with postoperative complications, especially POPF.
1 secondary outcome
Biomarker assessment
Time frame: Preoperative until postoperative day 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 32901324Gasteiger S, Primavesi F, Gobel G, Braunwarth E, Cardini B, Maglione M, Sopper S, Ofner D, Stattner S. Early Post-Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL-6 Predict Pancreatic Fistula. World J Surg. 2020 Dec;44(12):4236-4244. doi: 10.1007/s00268-020-05768-9. Epub 2020 Sep 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw in people with Postoperative Complications, run by Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Mar 2020. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presepsin (time frame: Preoperative until postoperative day 8.). 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 NCT04294797, which also lists 1 linked publication.
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 4 Mar 2020.