Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection (CLEAR)

Northwestern University

Status: Enrolling

Conditions: Colon Cancer Liver Metastases; Colorectal Cancer Metastatic; Liver Transplant Surgery

Treatments: Procedure: Resection And Partial Liver Transplantation With Delayed Total Hepatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06698146

STU00222933

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

80 participants in 4 patient groups

Living Donor Liver Transplant

Description:

Living Donor Liver Transplant using right or left lobe donor graft

RAPID Living Donor Liver Transplant (using LLS or left lobe)

Description:

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)

Description:

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)

Description:

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.