Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection

Not Applicable

Recruiting

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

• Registration Number: NCT06698146
• Lead Sponsor: Northwestern University

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).

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 Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Study Start: 2025-06-01
• Primary Completion: 2034-01-01
• Study Completion: 2035-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft and Patient Survival Outcomes	From liver transplant to 12 months	Graft survival will be measured as the time from transplantation to graft failure, or re-transplantation date.

Secondary Outcome Measures

Name	Time	Method
Outcomes of liver transplant recipients	From liver transplant to 12 months	Evaluate outcomes (e.g., complications or surgical outcomes) of liver transplant (LT) recipients.

Trial Locations

Locations (1)

Northwestern University-Comprehensive Transplant Center; 🇺🇸 Chicago, Illinois, United States