Post-operative Complication Clinical Trial
Official title:
The Predictor of Infectious Complication After Hepatopancreatobiliary Surgery and Monitoring Indicator of Anti-infectious Therapy
Post operative complication after hepatopancreatobiliary surgery is high as 30-50%，which is the main reason for patient admitted to ICU. Several biomarkers have been shown to be useful in the early diagnosis of sepsis and systemic bacterial infection. The purpose of this study is to assess the predictive value of biomarkers for early complication after hepatopancreatobiliary surgery and assess the effectiveness of anti-infectious therapy.
Postoperative complication after major abdominal surgery, such as pancreatic surgery and
hilar cholangiocarcinoma surgery, is higher, up to 30 to 50%.It is the mainly reason for the
patient to admit to ICU. Among this, the most common and difficult to handle complication is
mainly anastomotic fistula, abdominal effusion and subsequent secondary infection. Delayed
diagnosis can cause systemic inflammatory response syndrome (SIRS), multiple organ failure (
MODS), and even death. From a surgical point of view, it leads to surgical failure and often
need the second surgery. However, the diagnosis and treatment of postoperative infection is
also facing two problems: it is difficult to confirm the diagnosis and make treatment
decision. Hence, there is a strong need of an additional tool to early diagnose post
operative complication.
Serum procalcitonin (PCT), is a 116 amino-acids protein produced by C-cells of the thyroid
gland. PCT baseline levels are low (<0.05 ng/ml), but increase significantly in patients
with severe bacterial infections. Therefore, PCT levels are used to monitor the course and
prognosis of systemic bacterial infections and to tailor the therapeutic interventions more
efficiently. Furthermore, PCT could serve as an early predictive marker for the clinical
course of septic complications after abdominal surgery. The aim of this study is to
demonstrate if PCT is a more sensible, specific and reliable biomarker of post operative
complication than other biomarkers
The investigators conducted a observational, prospective study. All patients undergoing
electively hepatopancreatobiliary surgery in seven centres are recruited. In all cases white
blood count (WBC), C-reactive protein (CRP) and PCT levels are measured in 1st, 3rd and 5th
postoperative day (POD). Informed consent was obtained in all patients.The study is approved
by the hospital's Ethical Committee.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02406963 -
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
|
N/A |