Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06698146
Status
Recruiting
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Conditions

  • Colon Cancer Liver Metastases
  • Colorectal Cancer Metastatic
  • Liver Transplant Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

Start date
Aug 27, 2025
Status verified
Apr 2025
Primary completion
Jan 1, 2034
Completion
Jan 1, 2035

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Living Donor Liver Transplant
    Living Donor Liver Transplant using right or left lobe donor graft
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Graft and Patient Survival Outcomes [ Time Frame: From liver transplant to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University-Comprehensive Transplant CenterChicagoIllinois60611
Yajaira Navarro
[email protected]
312-694-2092
Zachary Dietch, MD, MBA (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University-Comprehensive Transplant Center· Chicago, IL

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