Recruiting

Colorectal Metastasis

Sponsor:

Northwestern University

Code:

NCT06698146

Conditions

Liver Transplant Surgery

Colorectal Cancer Metastatic

Colon Cancer Liver Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Liver Transplant Surgery

Colorectal Cancer Metastatic

Colon Cancer Liver Metastases

Study ID

NCT06698146

Start date

Aug 27, 2025

Status verified date

Jul, 2026

Completion date

Jan 1, 2035

Anticipated

Primary completion date

Jan 1, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Graft and Patient Survival Outcomes [ Time Frame: From liver transplant to 12 months ]

Central Contacts and Locations

Central contacts

Yajaira Navarro

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

Locations

Northwestern University-Comprehensive Transplant Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Yajaira Navarro

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

Principal Investigator:

Zachary Dietch, MD, MBA

More Information

Sponsor

Northwestern University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Liver Transplant
  • Colorectal Cancer Metastatic
  • Colorectal Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-10.