Medical University of Innsbruck
Innsbruck, Tyrol, 6020, Austria
NCT Number: NCT04294797
The study investigates the local and systemic inflammatory response following pancreatic resections.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Innsbruck, Tyrol, 6020, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One additional blood sample for study purpose from the day before surgery, postoperative 1, 3 and 8.
Time frame: Preoperative until postoperative day 8.
Correlation of Presespin values with postoperative complications, especially POPF.
Time frame: Preoperative until postoperative day 8.
Correlation of different biomarkers (CRP, IL-1, IL-6, IL-8, Procalcitonin) with operation associated postoperative complications after pancreatic resections.
Medical University Innsbruck
Other
Pilotstudie: Presepsin Als möglicher Prädiktor Postoperativer Komplikationen Nach Pankreasresektionen
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07719933
Digestive System Diseases, Digestive System Neoplasms
Guangzhou, Guangdong, China
View Trial DetailsNCT03972423
Anesthesia, Anesthesia Complication
Versailles, IDF, France
View Trial DetailsNCT04774354
Pathologic Processes, Pathological Conditions, Signs and Symptoms
Las Palmas de Gran Canaria, Las Palmas, Spain
View Trial DetailsNCT05379205
Behavior, Colon Cancer
Granada, Andalusia, Spain
View Trial Details