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The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887887
First Posted: April 24, 2009
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
  Purpose
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.

Condition
Liver Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association Between Gene Polymorphisms in the Innate Immune Response and the Risk of Infectious Complications and Liver Failure After Partial Hepatic Resection

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • post-resectional liver failure [ Time Frame: 90 days after liver surgery ]
  • mortality [ Time Frame: 90 days after liver surgery ]

Biospecimen Retention:   Samples With DNA
whole blood, fresh frozen liver tissue

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: January 2014
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
liver surgery
patients with benign or malignant hepatobiliary disease requiring partial hepatic resection

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre
Criteria

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
  Contacts and Locations
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): NCT00887887


Locations
Netherlands
Department of Surgery, Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Steven WM Olde Damink, MD, PhD, MSc Maastricht University Medical Centre
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00887887     History of Changes
Other Study ID Numbers: 08-4-022
First Submitted: April 23, 2009
First Posted: April 24, 2009
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by Maastricht University Medical Center:
liver surgery
gene polymorphisms
innate immune response
infectious complications
post-resectional liver failure
mortality

Additional relevant MeSH terms:
Liver Diseases
Communicable Diseases
Infection
Liver Failure
Digestive System Diseases
Hepatic Insufficiency