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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00887887

Enrollment

100

Registered

2009-04-24

Start date

2008-01-31

Completion date

2014-01-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

liver surgery, gene polymorphisms, innate immune response, infectious complications, post-resectional liver failure, mortality

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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)	90 days after liver surgery

Secondary

Measure	Time frame
post-resectional liver failure	90 days after liver surgery
mortality	90 days after liver surgery

Countries

Netherlands

Outcome results