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

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ClinicalTrials.gov Identifier: NCT02878668
Recruitment Status : Unknown
Verified August 2016 by Wenhui Lou, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Collaborators:
Changhai Hospital
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Harbin Medical University
Beijing Friendship Hospital
Information provided by (Responsible Party):
Wenhui Lou, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment
Post-operative Complication Procedure: hepatopancreatobiliary surgery

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Predictor of Infectious Complication After Hepatopancreatobiliary Surgery and Monitoring Indicator of Anti-infectious Therapy
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery


Intervention Details:
  • Procedure: hepatopancreatobiliary surgery
    hepatopancreatobiliary surgery


Primary Outcome Measures :
  1. post operative complication [ Time Frame: within the first 30 days after he operation ]

Secondary Outcome Measures :
  1. sepsis [ Time Frame: within the first 30 days after he operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
1000 elective hepatopancreatobiliary sugery hospitalized patients will be included
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878668


Contacts
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Contact: Wenhui Lou, MD 021-64041990 ext 3450 wenhuilou@aliyun.com
Contact: Wenchuan Wu, MD 021-64041990 ext 2909 wu.wenchuan@zs-hospital.sh.cn

Locations
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China, Beijing
Beijing Friendship hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Zhongtao Zhang, MD         
Principal Investigator: Zhongtao Zhang, MD         
Principal Investigator: Wei Guo, MD         
Sub-Investigator: Jiegao Zhu, MD         
China, Guangdong
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yajin Chen, MD         
Principal Investigator: Yajin Chen, MD         
Sub-Investigator: Jun Cao, MD         
China, Heilongjiang
The first affiliated hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Bei Sun, MD         
Principal Investigator: Bei Sun, MD         
Sub-Investigator: Xuewei Bai, MD         
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Kuirong Jiang, MD         
Principal Investigator: Kuirong Jiang, MD         
Sub-Investigator: Jishu Wei, MD         
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wenhui Lou, MD    021-64041990 ext 3450    wenhuilou@aliyun.com   
Contact: Wenchuan Wu, MD    021-64041990 ext 2909    wu.wenchuan@zs-hospital.sh.cn   
Principal Investigator: Wenhui Lou, MD         
Principal Investigator: Wenchuan Wu, MD         
Sub-Investigator: Yuan Fang, MD         
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Gang Jin, MD         
Principal Investigator: Gang Jin, MD         
Sub-Investigator: Kailian Zheng, MD         
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xubao Liu, MD         
Principal Investigator: Xubao Liu, MD         
Sub-Investigator: Hao Zhang, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Changhai Hospital
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Harbin Medical University
Beijing Friendship Hospital
Investigators
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Principal Investigator: Wenhui Lou, MD Shanghai Zhongshan Hospital

Publications:

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Responsible Party: Wenhui Lou, professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02878668     History of Changes
Other Study ID Numbers: ZS-LWH-2016
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Wenhui Lou, Shanghai Zhongshan Hospital:
procalcitonin
post-operative
complication
CRP

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Postoperative Complications
Pathologic Processes