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Trial record 2 of 81 for:    "Living Donors" | Recruiting, Not yet recruiting, Available Studies

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 : April 5, 2018
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Falk Rauchfuß, Jena University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Liver Metastases Procedure: Living donor liver transplantation with two-staged hepatectomy. Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases
Estimated Study Start Date : April 10, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Transplantation Arm Procedure: Living donor liver transplantation with two-staged hepatectomy.
Two-stage hepatectomy combined with transplantation of left-lateral lobe from a living donor.




Primary Outcome Measures :
  1. Overall survival three years after 2nd-stage of hepatectomy [ Time Frame: 3 years ]
    Overall survival three years after 2nd-stage of hepatectomy


Secondary Outcome Measures :
  1. Disease-free survival three years after 2nd-stage of hepatectomy [ Time Frame: 3 years ]
    Disease-free survival three years after 2nd-stage of hepatectomy

  2. Morbidity of the recipient [ Time Frame: 3 years ]
    all complications > grade IIIa according to the Clavien-Dindo classification

  3. Morbidity of the donor [ Time Frame: 3 years ]
    all complications > grade IIIa according to the Clavien-Dindo classification



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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

Locations
Germany
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    silvio.nadalin@med.uni-tuebingen.de   
Sponsors and Collaborators
Jena University Hospital
University Hospital Tuebingen

Responsible Party: Falk Rauchfuß, Senior Surgeon, Jena University Hospital
ClinicalTrials.gov Identifier: NCT03488953     History of Changes
Other Study ID Numbers: AVG-001
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Falk Rauchfuß, Jena University Hospital:
Liver transplantation
Two-stage hepatectomy
Living donor liver transplantation

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Liver Extracts
Hematinics