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NCT03488953Recruiting

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
15 Mar 2018
Start date
10 Apr 2018
Primary completion date
31 Dec 2026
Lead sponsor
Jena University Hospital
NCT number
NCT03488953

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 10 Apr 2018 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • comorbidities precluding liver transplantation
  • progression during chemotherapy

Other

  • extrahepatic tumor spread, except resectable pulmonary metastases

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jena University Hospital
Coordinator of this site? Confirm its status
JenaGermanyRecruiting
University Hospital Tübingen
Coordinator of this site? Confirm its status
TübingenGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.