Clinical trial NCT00887887: The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Disease
Keywords: liver surgery
gene polymorphisms
innate immune response
infectious complications
post-resectional liver failure
mortality
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre

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.

Eligibility 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

Primary outcomes:
measure: clinically significant infectious complications (i.e. wound infection, pneumonia, blood stream infection, gastro-intestinal infection, intra-abdominal infection, urinary tract infection and miscellaneous)
timeFrame: 90 days after liver surgery
Secondary outcomes:
measure: post-resectional liver failure
timeFrame: 90 days after liver surgery
measure: mortality
timeFrame: 90 days after liver surgery
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Surgery, Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Steven WM Olde Damink, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: