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The Value of Infectious Biomarkers for Prediction of Complication After Hepatopancreatobiliary Surgery

The Predictor of Infectious Complication After Hepatopancreatobiliary Surgery and Monitoring Indicator of Anti-infectious Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02878668
Enrollment
700
Registered
2016-08-25
Start date
2016-04-30
Completion date
2017-12-31
Last updated
2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Complication

Keywords

procalcitonin, post-operative, complication, CRP

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREhepatopancreatobiliary surgery

hepatopancreatobiliary surgery

Sponsors

Changhai Hospital
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \> = 18 years * Hospitalized patients with elective hepatopancreatobiliary surgery

Exclusion criteria

* age \<18 years * emergency operative patients * Preoperative fever, white blood cell elevation and preoperative infection * Systemic inflammatory disease * renal failure * hematology disease * preoperative abnormal PCT, IL-6, IL-8, CRP * Laparoscopic cholecystectomy * Bile duct infection

Design outcomes

Primary

MeasureTime frame
post operative complicationwithin the first 30 days after he operation

Secondary

MeasureTime frame
sepsiswithin the first 30 days after he operation

Countries

China

Contacts

Primary ContactWenhui Lou, MD
wenhuilou@aliyun.com021-64041990
Backup ContactWenchuan Wu, MD
wu.wenchuan@zs-hospital.sh.cn021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026