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: January 23, 2014
Last verified: January 2014
  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
Liver Surgery

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00887887     History of Changes
Other Study ID Numbers: 08-4-022
Study First Received: April 23, 2009
Last Updated: January 23, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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:
Communicable Diseases
Infection
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014