Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases (LIVERT(W)OHEAL)
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|ClinicalTrials.gov Identifier: NCT03488953|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : February 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Liver Metastases||Procedure: Living donor liver transplantation with two-staged hepatectomy.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases|
|Actual Study Start Date :||April 10, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 15, 2023|
Procedure: Living donor liver transplantation with two-staged hepatectomy.
Two-stage hepatectomy combined with transplantation of left-lateral lobe from a living donor.
- Overall survival three years after 2nd-stage of hepatectomy [ Time Frame: 3 years ]Overall survival three years after 2nd-stage of hepatectomy
- Disease-free survival three years after 2nd-stage of hepatectomy [ Time Frame: 3 years ]Disease-free survival three years after 2nd-stage of hepatectomy
- Morbidity of the recipient [ Time Frame: 3 years ]all complications > grade IIIa according to the Clavien-Dindo classification
- Morbidity of the donor [ Time Frame: 3 years ]all complications > grade IIIa according to the Clavien-Dindo classification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488953
|Contact: Falk Rauchfuss, M.D., M.Sc.||004936419322601||Falk.Rauchfuss@med.uni-jena.de|
|Contact: Ulrike McCaulley, Study Nurse||004936419322694||Ulrike.McCaulley@med.uni-jena.de|
|Jena University Hospital||Recruiting|
|Jena, Germany, 07747|
|Contact: Falk Rauchfuss, M.D., M.Sc. 004936419322601 Falk.Rauchfuss@med.uni-jena.de|
|Contact: Utz Settmacher, M.D. 004936419322601 Utz.Settmacher@med.uni-jena.de|
|University Hospital Tübingen||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Alfred Königsrainer, M.D. 004970712986620 Alfred.Koenigsrainer@med.uni-tuebingen.de|
|Contact: Silvio Nadalin, M.D. 004970712986600 email@example.com|