Liver transplantation in end-stage liver disease (particularly metabolic/nutritional cirrhosis)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Listed for elective liver transplantation at the participating centre. • Clinically stable at the time of informed consent. • Willingness and ability to provide preoperative stool samples and attend the specified follow-up appointments (up to 12 months). • Familiarity with the study requirements or sufficient language skills to understand the consent form and instructions.
Exclusion criteria
Exclusion criteria: • High-urgency or emergency transplantation (not a planned elective procedure), as preoperative samples and standardised information cannot be guaranteed. • Inability to give informed consent (e.g. lack of cognitive ability, lack of language skills without an interpreter), or unwillingness to participate/follow up. • Transplantation in combination with other organs (e.g. liver-kidney) or planned simultaneous major procedures if this significantly alters post-operative care and sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative change in the concentration of Enterococcus faecalis in bile (log10 cells/ml) across predefined perioperative time points of liver transplantation (explant liver, implanted liver intraoperatively, postoperative day 1, 7 and 14). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in concentrations of primary and secondary bile acids in bile (ng/ml) at predefined perioperative time points • Change in Torque Teno Virus load in blood (copies/ml) at predefined perioperative time points • Change in clinical liver function parameters (ALT, AST, bilirubin, albumin, INR) over time after transplantation | — |
Countries
Germany
Contacts
Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie