Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04874259
Status:
RECRUITING
Last Update Posted:
2022-09-06
First Post:
2021-05-02
Brief Title:
LT for Unresectable Colorectal Liver Metastasis
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis Pilot Study
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None