The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

October 13, 2014 updated by: Maastricht University Medical Center

The Association Between Gene Polymorphisms in the Innate Immune Response and the Risk of Infectious Complications and Liver Failure After Partial Hepatic Resection

The purpose of the study is to test whether the presence of polymorphisms in genes encoding substances of the innate immune response in patients undergoing partial hepatic resection because of benign or malignant hepatobiliary disease is related to a higher incidence of infectious complications, post-resectional liver failure or mortality.

Study Overview

Status

Completed

Conditions

Detailed Description

Partial hepatic resection is a feasible and relatively safe procedure for selected patients with benign or malignant hepatobiliary disease. Liver failure after partial hepatic resection, so-called post-resectional liver failure (PLF), is a dreaded complication with high mortality rates. Patients suffering from PLF experience significantly more clinically significant infections (CSI) when compared with patients without PLF. The liver plays an important role in the body's innate immune defense. Recently, polymorphisms in genes encoding key molecules in the innate immune response (e.g. nuclear factor kappa-B) have shown to be associated with a greater risk of CSI. The presence of these polymorphisms combined with partial hepatic resection might render patients susceptible to the development of CSI, PLF and early mortality after liver resection.

Study Type

Observational

Enrollment (Actual)

100

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

  • Netherlands
      • Maastricht, Netherlands
        • Department of surgery, Maastricht University Medical Centre

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

Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre

Description

Inclusion Criteria:

  • age >18 years
  • benign or malignant liver disease requiring partial hepatic resection

Exclusion Criteria:

  • inability to give informed consent
  • liver disease judged irresectable after intra-operative evaluation
  • use of immunosuppressive drugs
  • resection < 1 segment
  • unable to comply with follow-up

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

Cohorts and Interventions

Group / Cohort
liver surgery
patients with benign or malignant hepatobiliary disease requiring partial hepatic resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinically significant infectious complications (i.e. wound infection, pneumonia, blood stream infection, gastro-intestinal infection, intra-abdominal infection, urinary tract infection and miscellaneous)
Time Frame: 90 days after liver surgery
90 days after liver surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
post-resectional liver failure
Time Frame: 90 days after liver surgery
90 days after liver surgery
mortality
Time Frame: 90 days after liver surgery
90 days after liver surgery

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Steven WM Olde Damink, MD, PhD, MSc, Maastricht University Medical Centre

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

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-4-022

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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