Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorthwestern University

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Adults unable to consent

Pregnant Women

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 4 trial groups
Group A: Living Donor Liver Transplant
Group B: RAPID Living Donor Liver Transplant (using LLS or left lobe)
Group C: RAPID Deceased Donor Liver Transplant (LLS or left lobe)
Group D: Liver Transplant Deceased Donor (Whole Liver)

Trial outcomes

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.

Time frame
From liver transplant to 12 months

Secondary outcomes

1

Outcomes of liver transplant recipients

Evaluate outcomes (e.g., complications or surgical outcomes) of liver transplant (LT) recipients.

Time frame
From liver transplant to 12 months

Other outcomes

Sponsors and contacts

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