Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer Metastatic, Liver Metastases

In brief

Nearly one third of patients with colorectal cancer develop liver metastases. It is well known that the achievement of a R0-situation is one of the most important factors for a positive long-term outcome. Despite further advantages in multimodal treatment concepts, only 20 - 30 % of the patients with metastases can be resected in curative intention. Recent studies, especially from Norway, have shown that liver transplantation might be a feasible option in well selected patients since the complete hepatectomy with subsequent liver transplantation can be an option for the achievement of a R0 situation. In this study, we pursue the strategy of two-stage hepatectomy combined with a left-lateral living donor liver transplantation. Inclusion criteria are as follows: non-resectable liver metastases of a primary colorectal carcinoma with an assumed portal-venous drainage of the tumor and at least a "stable disease" after a period of eight weeks systemic chemotherapy. Patients are excluded from the study if there is an extrahepatic tumor burden (with the exception of resectable lung metastases) or if the patient is not suitable for liver transplantation due to co-morbidities. The transplantation itself will be undertaken as a living donor liver transplantation where the left lateral liver lobe (liver segments 2 \& 3) from a healthy volunteer donor will serve as graft. Prior transplantation, a left hemihepatectomy in the recipient is performed and the left lateral graft will be transplanted in this position. At the end of the transplantation procedure, the right portal vein will be closed to induce a rapid growth of the graft. The second step, and therefore the completion of the operation is performed after a growth period of the transplanted left-lateral lobe: in this procedure, the right hemi-liver of the recipient will be removed and the patient is supposed to be free of tumor at this point in time.

Key facts

Study ID

NCT03488953

Run by

Jena University Hospital

People needed

40

Starts

2018-04-10

Expected to finish

2027-12-31

Last updated by the study team

2024-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with irresectable colorectal liver metastases without extrahepatic tumor burden, except resectable pulmonary metastases
• stable disease or regression after at least eight weeks of systemic chemotherapy

You may not qualify if…

• comorbidities precluding liver transplantation
• extrahepatic tumor spread, except resectable pulmonary metastases
• progression during chemotherapy

Where it is running

• Jena University Hospital — Jena, Germany (enrolling)
• University Hospital Tübingen — Tübingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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