Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

NCT ID: NCT05248581

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-16

Study Completion Date

2027-08-01

Brief Summary

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The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Detailed Description

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The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.

Conditions

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Colorectal Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by the Liver transplantation team. Patients must demonstrate favorable tumor biology and no evidence of extra hepatic disease.

Liver transplantation

Intervention Type PROCEDURE

living donor liver transplantation

Interventions

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Liver transplantation

living donor liver transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Non-amenable to curative hepatic resection as defined by FLR \<30%
* Histologically confirmed adenocarcinoma of the colon or rectum
* Candidate for LDLT for colorectal liver metastasis per the University of Rochester liver transplant program

Exclusion Criteria

* Not a candidate of the LDLT liver transplant protocol for treatment of colorectal liver metastasis.
* Unwilling to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Roberto Hernandez-Alejandro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto Hernandez-Alejandro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Matthew Byrne, MD

Role: STUDY_DIRECTOR

University of Rochester

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Roberto Hernandez-Alejandro, MD

Role: CONTACT

585-275-5875

Jennie Errigo

Role: CONTACT

585-275-5875

Facility Contacts

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Roberto Hernandez-Alejandro, MD

Role: primary

Other Identifiers

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STUDY00004076

Identifier Type: -

Identifier Source: org_study_id

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