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Perfusionsstudie
| Prüfplancode | ISRCTN | EudraCT | Clinicaltrials.gov | DRKS |
|---|---|---|---|---|
| 78500982 |
Prospektiv randomisierte Multicenterstudie zum Vergleich der Leberkonservierung mit HTK-Lösung durch Aortenperfusion gegenüber HTK-Lösung durch Aortenperfusion und arterielle ex-situ-Nachperfusion
Status: Aktiv (Rekrutierung geschlossen)
Studienziel / Fragestellung
Primäres Prüfziel
Does Ischaemic Type Biliary Lesions (ITBL) occur less frequently in a liver preserved by aortic perfusion plus ex situ arterial flushing than in a liver preserved by simple aortic perfusion?
Diagnose
Lebertransplantation
Patientenmerkmale
Alter
18-80
Einschlusskriterien
For the graft:
1. Liver graft retrieved in the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation [DSO])
2. Donor 18 - 80 years
3. Graft allocation to a participating centre
For the recipient
1. Informed consent
2. Age 18 - 80 years
3. Standard criteria for liver transplantation (e.g. liver dysfunction because of cirrhosis, carcinoma)
Ausschlusskriterien
For the graft:
1. Liver cirrhosis
2. Liver intoxication
3. Liver dysfunction
4. Liver trauma
5. Graft not transplantable (decision according to Standard Operating Procedures [SOP])
6. Liver split
For the recipient:
1. Standard criteria for liver transplantation
Studiendesign
Intervention
Aortic in situ perfusion versus aortic in situ perfusion plus arterial back-table ex situ flushing.
At the beginning of the process of abdominal dissection, a tube is placed into the abdominal aorta (or into a common iliac artery). The perfusate (HTK [Histidine-Tryptophan-Ketoglutarate] solution) is connected to this tube. Usually a perfusion pressure of 100 to 150 cm water column is applied which is realised by elevation of the plastic bag containing the fluid. When the liver is dissected free in order to be retrieved the perfusion is started. At least 8000 ml of solution have to be used.
In the control group the approach of preservation is stopped at this point, the liver is retrieved, put into plastic bags containing preservation solution and is forwarded to the transplant centre of the respective patients to whom the graft was allocated by Eurotransplant.
In the case of additional ex-situ arterial perfusion, the liver is retrieved and placed into an ice water dish. There all branches of the hepatic artery are tied, a cannula is placed into the artery at is origin and the ex-situ perfusion is performed. For ex-situ perfusion, 300 ml of the perfusate at a pressure of 100 cm water column is used. After that procedure, the graft is forwarded in the identical way as for non-ex-situ perfused grafts.
The transplantation itself is going to be performed at the discretion of the respective centre. Follow-up will be six months.
Dokumente (passwortgeschützt)
Zum Downloadbereich (noch keine Dokumente)
Zuständigkeiten Gesamtstudie
Sponsor
Universität Mainz
Projektmanagement
Chirurgisches Regionalzentrum Mainz
Dr. rer. nat. Kai Kronfeld