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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Jena University Hospital
RECRUITING
Jena
University Hospital Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Falk Rauchfuss, M.D., M.Sc.
Falk.Rauchfuss@med.uni-jena.de
004936419322601
Backup
Ulrike McCaulley, Study Nurse
Ulrike.McCaulley@med.uni-jena.de
004936419322694
Time Frame
Start Date: 2018-04-10
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Other: Transplantation Arm
Sponsors
Collaborators: University Hospital Tuebingen
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov