The Value of Infectious Biomarkers for Prediction of Complication After Hepatopancreatobiliary Surgery
NCT ID: NCT02878668
Last Updated: 2016-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
700 participants
OBSERVATIONAL
2016-04-30
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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hepatopancreatobiliary surgery
hepatopancreatobiliary surgery
Eligibility Criteria
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Inclusion Criteria
* Hospitalized patients with elective hepatopancreatobiliary surgery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
West China Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Beijing Friendship Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Wenhui Lou
professor
Principal Investigators
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Wenhui Lou, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Beijing Friendship hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University
Guangzhou, Guangdong, China
The first affiliated hospital of Harbin Medical University
Harbin, Heilongjiang, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Zhongtao Zhang, MD
Role: primary
Yajin Chen, MD
Role: primary
Bei Sun, MD
Role: primary
Kuirong Jiang, MD
Role: primary
Gang Jin, MD
Role: primary
Xubao Liu, MD
Role: primary
References
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Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.
Mofidi R, Suttie SA, Patil PV, Ogston S, Parks RW. The value of procalcitonin at predicting the severity of acute pancreatitis and development of infected pancreatic necrosis: systematic review. Surgery. 2009 Jul;146(1):72-81. doi: 10.1016/j.surg.2009.02.013. Epub 2009 May 8.
Rau BM, Frigerio I, Buchler MW, Wegscheider K, Bassi C, Puolakkainen PA, Beger HG, Schilling MK. Evaluation of procalcitonin for predicting septic multiorgan failure and overall prognosis in secondary peritonitis: a prospective, international multicenter study. Arch Surg. 2007 Feb;142(2):134-42. doi: 10.1001/archsurg.142.2.134.
Novotny AR, Emmanuel K, Hueser N, Knebel C, Kriner M, Ulm K, Bartels H, Siewert JR, Holzmann B. Procalcitonin ratio indicates successful surgical treatment of abdominal sepsis. Surgery. 2009 Jan;145(1):20-6. doi: 10.1016/j.surg.2008.08.009. Epub 2008 Sep 26.
Limper M, de Kruif MD, Duits AJ, Brandjes DP, van Gorp EC. The diagnostic role of procalcitonin and other biomarkers in discriminating infectious from non-infectious fever. J Infect. 2010 Jun;60(6):409-16. doi: 10.1016/j.jinf.2010.03.016. Epub 2010 Mar 27.
Tavares E, Maldonado R, Ojeda ML, Minano FJ. Circulating inflammatory mediators during start of fever in differential diagnosis of gram-negative and gram-positive infections in leukopenic rats. Clin Diagn Lab Immunol. 2005 Sep;12(9):1085-93. doi: 10.1128/CDLI.12.9.1085-1093.2005.
Scapini P, Lapinet-Vera JA, Gasperini S, Calzetti F, Bazzoni F, Cassatella MA. The neutrophil as a cellular source of chemokines. Immunol Rev. 2000 Oct;177:195-203. doi: 10.1034/j.1600-065x.2000.17706.x.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9. doi: 10.1097/01.sla.0000246856.03918.9a.
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
Other Identifiers
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ZS-LWH-2016
Identifier Type: -
Identifier Source: org_study_id
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