Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03488953

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

Led by Jena University Hospital · Updated on 2024-07-31

40

Participants Needed

2

Research Sites

507 weeks

Total Duration

On this page

Sponsors

J

Jena University Hospital

Lead Sponsor

U

University Hospital Tuebingen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Comorbidities precluding liver transplantation
  • Extrahepatic tumor spread, except resectable pulmonary metastases
  • Tumor progression during chemotherapy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Jena University Hospital

Jena, Germany, 07747

Actively Recruiting

2

University Hospital Tübingen

Tübingen, Germany, 72076

Actively Recruiting

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Research Team

F

Falk Rauchfuss, M.D., M.Sc.

CONTACT

U

Ulrike McCaulley, Study Nurse

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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