The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 23, 2009 | ||||
| Last Updated Date | June 10, 2010 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
clinically significant infectious complications (i.e. wound infection, pneumonia, blood stream infection, gastro-intestinal infection, intra-abdominal infection, urinary tract infection and miscellaneous) [ Time Frame: 90 days after liver surgery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00887887 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery | ||||
| Official Title ICMJE | The Association Between Gene Polymorphisms in the Innate Immune Response and the Risk of Infectious Complications and Liver Failure After Partial Hepatic Resection | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: whole blood, fresh frozen liver tissue |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | liver surgery
patients with benign or malignant hepatobiliary disease requiring partial hepatic resection |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2011 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00887887 | ||||
| Other Study ID Numbers ICMJE | 08-4-022 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Steven WM Olde Damink, Maastricht University Medical Centre | ||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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