Trials / Recruiting
RecruitingNCT04874259
LT for Unresectable Colorectal Liver Metastasis
Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis; Pilot Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
Unlike hepatocellular carcinoma, liver transplantation in patients with liver metastasis from colorectal cancer is limited in only few centers. Previously, it was not generally implemented due to lack of organs and high recurrence rates after transplantation. However, due to progressive development in treatments, good results such as increased survival rates can be expected even in liver transplant patients with liver metastasis from colorectal cancer, which is known to have poor prognosis. Therefore, the purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.
Detailed description
Surgical treatment offers a distinct survival benefit in liver metastasis of colorectal cancer (CRC LM). However, it has been estimated that only 40% of patients are candidates for curative liver resection. Liver transplantation can be considered as one of a treatment option, since all evident disease is removed during procedure. However, it is limited in only few centers due to lack of organs and high recurrence rates after transplantation. Currently, with help of development in treatments, prognosis after LT in CRC LM is improving. Recent study of LT for CRC LM from Norway demonstrated a 5-year survival of 56%. In addition, cohort study and randomized controlled trials are ongoing in Germany and Canada. Therefore, it seems to be necessary to verify the effectiveness of liver transplantation for CRC LM and to verify it as an alternative treatment if there is no other treatment. The purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer. Potential participants will be evaluated for liver transplantation and must also have a willing, healthy living donor. Unresectable metastasis should be limited to the liver and stable without no other treatment such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation. The suitability of liver transplantation will be evaluated through a multidisciplinary assessment immediately before transplantation. Those participants who undergo liver transplantation will be followed for survival, disease-free survival, and recurrence for 3 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Living donor liver transplantation | Living donor liver transplantation |
Timeline
- Start date
- 2022-08-22
- Primary completion
- 2023-05-01
- Completion
- 2026-05-01
- First posted
- 2021-05-05
- Last updated
- 2022-09-06
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04874259. Inclusion in this directory is not an endorsement.