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

August 24, 2016 updated by: Wenhui Lou, Shanghai Zhongshan Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
          • Zhongtao Zhang, MD
        • Principal Investigator:
          • Zhongtao Zhang, MD
        • Principal Investigator:
          • Wei Guo, MD
        • Sub-Investigator:
          • Jiegao Zhu, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital，Sun Yat-sen University
        • Contact:
          • Yajin Chen, MD
        • Principal Investigator:
          • Yajin Chen, MD
        • Sub-Investigator:
          • Jun Cao, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Bei Sun, MD
        • Principal Investigator:
          • Bei Sun, MD
        • Sub-Investigator:
          • Xuewei Bai, MD
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Kuirong Jiang, MD
        • Principal Investigator:
          • Kuirong Jiang, MD
        • Sub-Investigator:
          • Jishu Wei, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
          • Gang Jin, MD
        • Principal Investigator:
          • Gang Jin, MD
        • Sub-Investigator:
          • Kailian Zheng, MD
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wenhui Lou, MD
        • Principal Investigator:
          • Wenchuan Wu, MD
        • Sub-Investigator:
          • Yuan Fang, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Xubao Liu, MD
        • Principal Investigator:
          • Xubao Liu, MD
        • Sub-Investigator:
          • Hao Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

1000 elective hepatopancreatobiliary sugery hospitalized patients will be included

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post operative complication
Time Frame: within the first 30 days after he operation
within the first 30 days after he operation

Secondary Outcome Measures

Outcome Measure
Time Frame
sepsis
Time Frame: within the first 30 days after he operation
within the first 30 days after he operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

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

Investigators

  • Principal Investigator: Wenhui Lou, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-LWH-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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