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

Post-operative Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878668
• Other study ID #: ZS-LWH-2016
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: August 24, 2016
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Shanghai Zhongshan Hospital
• Contact: Wenhui Lou, MD
• Phone: 021-64041990
• Email: wenhuilou[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Post-operative Complication
• Postoperative Complications

Intervention

Procedure:
• hepatopancreatobiliary surgery
hepatopancreatobiliary surgery

Locations

Country	Name	City	State
China	Beijing Friendship hospital, Capital Medical University	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
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	Changhai Hospital	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (7)

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

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Rau BM, Frigerio I, Büchler 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. — View Citation

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. Review. — View Citation

Tavares E, Maldonado R, Ojeda ML, Miñano 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative complication		within the first 30 days after he operation	Yes
Secondary	sepsis		within the first 30 days after he operation	Yes