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Sponsored by: |
Maastricht University Medical Center |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00887887 |
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.
Condition |
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Liver Disease Liver Surgery |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
whole blood, fresh frozen liver tissue
Estimated Enrollment: | 100 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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liver surgery
patients with benign or malignant hepatobiliary disease requiring partial hepatic resection
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven WM Olde Damink, MD, PhD, MSc | +31433874356 | steven.oldedamink@ah.unimaas.nl |
Contact: Maartje AJ van den Broek, MD | +31433884502 | m.vandenbroek@ah.unimaas.nl |
Netherlands | |
Department of Surgery, Maastricht University Medical Centre | Recruiting |
Maastricht, Netherlands | |
Contact: Steven WM Olde Damink, MD, PhD, MSc +31433874356 steven.oldedamink@ah.unimaas.nl | |
Contact: Maartje AJ van den Broek, MD +31433884502 m.vandenbroek@ah.unimaas.nl | |
Principal Investigator: Steven WM Olde Damink, MD, PhD, MSc |
Principal Investigator: | Steven WM Olde Damink, MD, PhD, MSc | Maastricht University Medical Centre |
Responsible Party: | Maastricht University Medical Centre ( Steven WM Olde Damink ) |
Study ID Numbers: | 08-4-022 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887887 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
liver surgery gene polymorphisms innate immune response |
infectious complications post-resectional liver failure mortality |
Liver Failure Liver Diseases Digestive System Diseases |
Liver Diseases Digestive System Diseases |