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OpenTrials
Completed

NCT Number: NCT00887887

The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

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.

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Maastricht University Medical Centre

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. post-resectional liver failure

    Time frame: 90 days after liver surgery

  2. mortality

    Time frame: 90 days after liver surgery

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2014
First posted
Apr 24, 2009
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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