Liver DiseaseNCT00887887
The Association Between Gene Polymorphisms and Infectious Complications After Liver Surgery
An observational study of Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre
Who may be able to join
- age >18 years
- benign or malignant liver disease requiring partial hepatic resection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Surgery, Maastricht University Medical Centre
Maastricht
About this study
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
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.
Read the 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.
- Conditions
- Liver Disease
- Keywords
- liver surgery, gene polymorphisms, innate immune response, infectious complications, post-resectional liver failure, mortality
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver surgery | patients with benign or malignant hepatobiliary disease requiring partial hepatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically significant infectious complications (i.e. wound infection, pneumonia, blood stream infection, gastro-intestinal infection, intra-abdominal infection, urinary tract infection and miscellaneous)
Measured: 90 days after liver surgery
Secondary outcomes (2)
post-resectional liver failure
Measured: 90 days after liver surgery
mortality
Measured: 90 days after liver surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven WM Olde Damink, MD, PhD, MSc, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887887
- Sponsor's protocol ID
- 08-4-022
- Status last verified
- Oct 2014
- First submitted
- 23 Apr 2009
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00887887
- Acronym / sponsor ID
- 08-4-022
- Conditions
- Liver Disease
- Keywords
- liver surgery, gene polymorphisms, innate immune response, infectious complications, post-resectional liver failure, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver surgery | – | –patients with benign or malignant hepatobiliary disease requiring partial hepatic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre
Key inclusion criteria (2 listed)
- age >18 years
- benign or malignant liver disease requiring partial hepatic resection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
post-resectional liver failure
Time frame: 90 days after liver surgery
mortality
Time frame: 90 days after liver surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven WM Olde Damink, MD, PhD, MSc principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.