Living donor liver transplantation for non-resectable colorectal liver metastases

JRCT ID: jRCT1050230053

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-resectable colorectal liver metastases
• Date of first enrollment: 31/12/2023
• Target sample size: 23
• Study type: Interventional
• Intervention(s): Living donor liver transplantation

Outcome(s)

• Primary Outcome: 3 year overall survival

Secondary Outcome

1. Short-term (from living donor liver transplantation to discharge from hospital) outcomes of living donor liver transplantation.
Operative time, blood loss, perioperative complications (type, severity, treatment details, date of occurrence, and outcomes), and in-hospital mortality rates.
2. Short-term (within 90 days of living donor liver transplantation) results of living donor liver transplantation
Survival rate at 30 days and 90 days after transplantation.
3. Tumour recurrence rate, type of recurrence, and type of treatment for the recurrence tumour
4. Adverse events other than tumour recurrence after transplantation
5. Two- and three-year recurrence-free survival rates and graft survival rates after transplantation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

A: criteria for the disease
1. Histological evidence of colorectal adenocarcinoma
2. Genetic examination for RAS, BRAFV600E, MSI, and mismatch repair gene
3. Primary colorectal cancer was curatively resected.
4. Liver metastases from colorectal cancer were diagnosed as surgically non-resectable, including those after repeated hepatectomies. Non-resectable cases are associated with the risk of PHLF owing to insufficient remnant liver volume or function.
Non-resectable means the following cases (i) and (ii),
(i) Cases in which there is concern of liver failure due to anatomical inability to secure sufficient volume in the remaining liver.
Cases in which the residual liver volume does not allow approximately 30% of the total liver volume after resection, or in which tumor invasion of the major vessels makes it difficult to maintain blood flow to the residual liver.
(ii) When there is concern about liver failure due to inadequate function of the residual liver caused by liver dysfunction.
When the K-ICG value of the residual liver is less than 0.05 in the ICG test.
5. Based on the imaging diagnosis, the metastatic lesion was only present in the liver. Diagnostic imaging modalities include contrast-enhanced computed tomography, magnetic resonance imaging, and fluorodeoxyglucose-positron emission tomography.
6. No history of distant metastases, except in the liver. However, patients with no more than three lung metastases without recurrence for more than six months after treatment are eligible as exceptions.
7. medical therapy was administered more than three months before enrolment.
8. Patients who are at least 18 years old and give written consent to this study.

B. Conventional criteria for LDLT
1. Age is >18, <70
2. PS 0 or 1
3. Main organ function is maintained as follows,
- Neut: > 1,500/uL
- Plt: > 30,000/uL
- Hb: > 7.5 g/dL
- Cre: <1.5 mg/dL
- NYHA class II or lower.
- Hugh-Jones class II or lower.

Exclude criteria

1. Diagnosed as progressive disease after medical therapy evaluated using RESIST version 1.1.
2. An infectious disease requiring treatment
3. Pregnancy
4. Psychiatric disorder or psychiatric symptoms that interfere with daily life and make it difficult to participate in the study
5. Other cases considered as not eligible for living-donor liver transplantation at each participating institution.

Related Information

• Primary Sponsor: Hatano Etsuro
• Secondary ID(s): UMIN000049785