Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

Colorectal Cancer Metastatic Clinical Trial

Official title:

Liver Transplantation From Living Donors For Treatment Of Non-Resectable Colorectal Carcinoma Liver Metastases: A Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248581
• Other study ID #: STUDY00004076
• Status: Recruiting
• Start date: August 16, 2019
• Est. completion date: August 1, 2027

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Roberto Hernandez-Alejandro, MD
• Phone: 585-275-5875
• Email: roberto_hernandez[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Neoplasm Metastasis

Intervention

Procedure:
• Liver transplantation
living donor liver transplantation

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with recurrence free survival	RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis	5 years
Primary	percentage overall survival	OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis	5 years