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

Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Metastatic; Liver Transplant Surgery; Colon Cancer Liver Metastases
• Intervention / Treatment: Procedure: Resection And Partial Liver Transplantation With Delayed Total Hepatectomy

Detailed Description

The CLEAR protocol will evaluate the feasibility of RAPID for LT recipients with CRLM and compare important post-transplant outcomes after RAPID with conventional LT approaches. We expect that the findings from this innovative protocol will transform the current approach to patients with CRLMs by expanding donor organ supply and offering a widely available, life-saving treatment to a large cohort of patients with no options other than palliative chemotherapy at the present time.

Aim 1:

We will compare graft and patient survival in LT recipients transplanted with the RAPID technique (intervention group) versus conventional LT methods (control group).

Hypothesis:

We hypothesize that RAPID LT for CRLMs will demonstrate acceptable and comparable post-transplant outcomes to conventional living donor LT and deceased donor LT.

• Study Type: Observational
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yajaira Navarro; Phone Number: 312-694-2092; Email: a-daud@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University-Comprehensive Transplant Center
      • Contact: Yajaira Navarro; Phone Number: 312-694-2092; Email: a-daud@northwestern.edu
      • Principal Investigator: Zachary Dietch, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes of liver transplant recipients	Evaluate outcomes (e.g., complications or surgical outcomes) of liver transplant (LT) recipients.	From liver transplant to 12 months

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2035

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colorectal Cancer Metastatic; Liver Transplant
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STU00222933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No