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The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00887887
First received: April 23, 2009
Last updated: October 13, 2014
Last verified: October 2014

April 23, 2009
October 13, 2014
January 2008
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887887 on ClinicalTrials.gov Archive Site
  • post-resectional liver failure [ Time Frame: 90 days after liver surgery ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 90 days after liver surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, fresh frozen liver tissue

Probability Sample

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

Liver Disease
Not Provided
liver surgery
patients with benign or malignant hepatobiliary disease requiring partial hepatic resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2014
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00887887
08-4-022
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Steven WM Olde Damink, MD, PhD, MSc Maastricht University Medical Centre
Maastricht University Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP