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Purpose

Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion:

1. All Patients of either gender ≥ 18 years of age who are listed for Liver transplant
candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).

2. Subjects must be able to provide informed consent themselves and without the use of
a legally authorized representative (LAR), to be determined by the PI or Sub-I at
the time of Consent.

Exclusion:

1. Adults unable to consent

2. Pregnant Women

3. Certain clinical/surgical/anatomical parameters, at the discretion of the PI.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Living Donor Liver Transplant Living Donor Liver Transplant using right or left lobe donor graft
RAPID Living Donor Liver Transplant (using LLS or left lobe) Resection And Partial Liver Transplantation with Delayed Total Hepatectomy is a two staged procedure that utilized partial donor grafts and stages hepatectomies. In the first stage, a left hepatectomy is performed and a LT is performed using a donor left lateral segment split (LLS) (or left lobe split in some circumstances). Once the LT has achieved sufficient volume (typically within two weeks), a right hepatectomy is performed to remove all native liver, leaving the LT intact.
RAPID Deceased Donor Liver Transplant (LLS or left lobe) Resection And Partial Liver Transplantation with Delayed Total Hepatectomy is a two staged procedure that utilized partial donor grafts and stages hepatectomies. In the first stage, a left hepatectomy is performed and a LT is performed using a donor left lateral segment split (LLS) (or left lobe split in some circumstances). Once the LT has achieved sufficient volume (typically within two weeks), a right hepatectomy is performed to remove all native liver, leaving the LT intact.
Liver Transplant Deceased Donor (Whole Liver) The whole of the deceased donor liver is used. Livers from deceased donors are allocated to potential recipients according to the MELD (Model for End-Stage Liver Disease) scoring system.

Recruiting Locations

Northwestern University-Comprehensive Transplant Center
Chicago, Illinois 60611
Contact:
Yajaira Navarro
312-694-2092
a-daud@northwestern.edu

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Yajaira Navarro
312-694-2092
a-daud@northwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.