The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery

NCT ID: NCT00887887

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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liver surgery

patients with benign or malignant hepatobiliary disease requiring partial hepatic resection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven WM Olde Damink, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

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Department of Surgery, Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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08-4-022

Identifier Type: -

Identifier Source: org_study_id

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