Liver Transplant SurgeryCLEARNCT06698146
Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection
An observational study of Liver Transplant Surgery and Colorectal Cancer Metastatic, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Surgery, Colorectal Cancer Metastatic, Colon Cancer Liver Metastases
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 1 Jan 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Northwestern University participants with liver metastases due to colorectal cancer (CRLM) who are eligible to liver transplant candidates
Who may be able to join
- 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.
Who cannot join
- Adults unable to consent
- Pregnant Women
- Certain clinical/surgical/anatomical parameters, at the discretion of the PI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University-Comprehensive Transplant Center
Chicago, Illinois, 60611
Yajaira Navarro, 312-694-2092, a-daud@northwestern.edu
Zachary Dietch, MD, MBA
About this study
Official title: Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study
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).
- Keywords
- Liver Transplant, Colorectal Cancer Metastatic, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Living Donor Liver Transplant | Living Donor Liver Transplant using right or left lobe donor graft | |
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft and Patient Survival Outcomes
Graft survival will be measured as the time from transplantation to graft failure, or re-transplantation date.
Measured: 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.
Measured: From liver transplant to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start27 Aug 2025
- Primary completion1 Jan 2034 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant SurgeryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary Dietch, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698146
- Sponsor's protocol ID
- STU00222933
- Acronym
- CLEAR
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No