An observational study in Liver Diseases, sponsored by University of Leicester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Leicester · Observational
The human immune response to bacterial and viral local and systemic infection are fairly well understood, but we lack details on the earliest phases. Better knowledge of these events would be important for the prevention and treatment of severe bacterial or viral disease. From models of infection, we have data showing that bacteria replicate in a specific type of cells in the liver from where the bacteria then seed to the blood to cause blood stream infection. In order to gain more relevant data for humans, we have developed a spleen and liver perfusion model using pig organs. This model confirms our previous work and most importantly will now allow us to study these events in human organs.
Primary Objectives: The primary objective of the study is to identify therapies acting on the initial events during invasive bacterial and viral infection.
Secondary Objectives: The secondary objective of this study is to provide novel in vitro and ex vivo models of human liver macrophages to study the impact of therapies for invasive infection.
The Primary Endpoint of the study is to increase the resistance of liver macrophages to infection at least tenfold after treatment.
The Primary Outcome Measure of the study is the reduction of bacterial or viral load at pre-determined time-points.
This is a preclinical research project and no patient intervention is planned. The project makes use of anonymised human tissue samples discarded during radical surgery. The liver segment samples included in this project will be from patients undergoing elective surgery for a lesion in the liver in the HPB Unit of the Leicester General Hospital. The sample size of 96 patiens (46 liver segments) has been determined by power calculations and is in line with the number of livers actually removed by elective liver surgery over the past years. No change in the surgical procedure or recruiting results from this study and the use of the samples. All the experimental work carried out on the liver samples will have no effect on the patient.
Experiments include ex vivo organ segment perfusion and infection with bacteria or viruses. Biopsies of the perfused 46 liver segments are processed for in vitro tissue slice and macrophage cell culture. The resulting primary cell cultures and tissue slices will be stored frozen for future research. All in vitro studies on the 46 liver segments, and the tissues and cells derived from them, will evaluate the effect of therapeutic interventions (antibodies, receptor antagonists, antibiotics and other molecules) on the capacity of liver cells to clear invasive bacteria or viruses. The experiments will be carried out each time a liver sample will be available.
The detailed technical description of the experimental strategy including the strategy for storage and discarding of the human tissue will be as follows:
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 36 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
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The liver segment samples included in this project will be from patients undergoing elective surgery for a lesion in the liver in the HPB Unit of the Leicester General Hospital. No change in the surgical procedure or recruiting results from this study and the use of the samples.
Exclusion Criteria:
Overall Description of Trial Participants: The liver organ samples included in this project will be from patients undergoing elective surgery for a lesion in the liver in the HPB Unit of the Leicester General Hospital. No change in the surgical procedure or recruiting results from this study and the use of the samples. Inclusion Criteria: The samples included in this project will be from patients undergoing elective liver surgery in the HPB Unit of the Leicester General Hospital. The criteria for inclusion of liver segment samples from radical surgery are adult age and presence of hepatic tissue in the discarded material after hepato-pancreato-biliary surgery. Exclusion Criteria: The main exclusion criterion is acute invasive infection, but these patients are automatically excluded from major surgery. Vulnerable groups will not be recruited.
Other: organ and tissue sample collection only
Collection of liver segments removed by radical surgery of hepatic lobes, but not submitted to pathology
Reduction of the load and replication of infectious agents by host directed interventions
Reduction of the number of infectious agents per gram of tissue by therapies acting on the initial events during invasive infection.
Time frame: 3.5 Years
Protocol for seven-day survival of tissue slices and primary macrophage cell cultures
Protocol for seven-day survival of tissue slices and primary macrophage cell cultures to study in vitro therapies for invasive infection
Time frame: 3.5 Years
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University of Leicester