The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887887
• Other study ID #: 08-4-022
• Status: Completed
• Phase: N/A
• First received: April 23, 2009
• Last updated: October 13, 2014
• Start date: January 2008
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
Netherlands	Department of Surgery, Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	post-resectional liver failure		90 days after liver surgery	No
Secondary	mortality		90 days after liver surgery	No