Colorectal Metastasis to Liver Extraction with Auxiliary Transplant and Delayed Resection - the CLEAR Trial

Northwestern University

Status: Not yet 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: Interventional

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) but the scarcity of donor organs can create a difficult pathway to transplant for these patients. Resection And Partial Liver Transplantation With Delayed Total Hepatectomy (RAPID) is a described technique that combines staged liver resections with partial LT to enable LT in patients with CRLM.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

1. Adults unable to consent
2. Pregnant Women
3. Certain clinical/surgical/anatomical parameters at the discretion of the PI.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

RAPID- Deceased Donor Transplant

Experimental group

Description:

RAPID-Deceased Donor Transplant

Treatment:

Procedure: Resection And Partial Liver Transplantation With Delayed Total Hepatectomy

RAPID Living Donor Liver Transplant

Experimental group

Description:

RAPID Living Donor Liver Transplant

Treatment:

Procedure: Resection And Partial Liver Transplantation With Delayed Total Hepatectomy

Standard of Care/Conventional Living Donor Liver Transplant

No Intervention group

Description:

Standard of Care/Conventional Living Donor Liver Transplant

Standard of Care/Conventional Deceased Donor Whole Liver Transplant

No Intervention group

Description:

Standard of Care/Conventional Deceased Donor Whole Liver Transplant