Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection

NCT06698146 | Recruiting

• 1 other identifier: STU00222933
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

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

Keywords

Liver Transplant; Colorectal Cancer Metastatic; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Graft and Patient Survival Outcomes

  Graft survival will be measured as the time from transplantation to graft failure, or re-transplantation date.

  From liver transplant to 12 months

Secondary Outcomes (1)

• Outcomes of liver transplant recipients

  From liver transplant to 12 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Northwestern University participants with liver metastases due to colorectal cancer (CRLM) who are eligible to liver transplant candidates

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Adults unable to consent
• Pregnant Women
• Certain clinical/surgical/anatomical parameters, at the discretion of the PI.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University-Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yajaira Navarro

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Surgery (Organ Transplant)

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start: August 27, 2025
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2035
• Last Updated: February 10, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)