Liver Transplant Technique for Colorectal Cancer
(CLEAR Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

This trial is for patients with colorectal cancer that has spread to the liver and cannot be removed with surgery alone. Candidates must not have had previous liver transplants or other treatments that would exclude them from a partial transplant followed by delayed total hepatectomy.

Inclusion Criteria

I can understand and agree to the study details on my own.

I am 18 or older, listed for a liver transplant at Northwestern due to colorectal cancer spread to my liver.

Exclusion Criteria

I am unable to give consent for medical procedures.

Pregnant women

Certain clinical/surgical/anatomical parameters at the discretion of the PI.

Treatment Details

Interventions

Resection And Partial Liver Transplantation With Delayed Total Hepatectomy (Procedure)

Trial OverviewThe CLEAR Trial is testing a technique called RAPID, which involves staged liver resections combined with a partial liver transplant, followed later by complete removal of the liver, in patients whose colorectal cancer has metastasized to the liver.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: RAPID- Deceased Donor TransplantExperimental Treatment1 Intervention

RAPID-Deceased Donor Transplant

Group II: RAPID Living Donor Liver TransplantExperimental Treatment1 Intervention

RAPID Living Donor Liver Transplant

Group III: Standard of Care/Conventional Living Donor Liver TransplantActive Control1 Intervention

Standard of Care/Conventional Living Donor Liver Transplant

Group IV: Standard of Care/Conventional Deceased Donor Whole Liver TransplantActive Control1 Intervention

Standard of Care/Conventional Deceased Donor Whole Liver Transplant