The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

Completed

• Conditions: Liver Disease

• Registration Number: NCT00887887
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Primary Completion: 2010-06
• Study Completion: 2014-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
post-resectional liver failure	90 days after liver surgery
mortality	90 days after liver surgery

Trial Locations

Locations (1)

Department of Surgery, Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands