Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539377
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Living Donor Liver Transplantation for Neoadjuvant Treated Unresectable Intrahepatic Cholangiocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIVINCA
Brief Summary:
This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma Donor organ shortage is currently the main problem for organ transplantation world-wide Thus the particular indication non-resectable intrahepatic cholangiocarcinoma is currently excluded in terms of transplantation Given those circumstances transplantation via living donation might be the best option This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients not subsidiary
Detailed Description:
Intrahepatic cholangiocarcinoma iCCA is classified among primary liver tumors and has demonstrated a consistently increasing incidence in recent years Due to the poor long-term survival rates reported in older studies liver transplantation continues to be a contraindication in the curative treatment of iCCA The persistent shortage of organs also necessitates that each new indication for transplantation be carefully evaluated and critically scrutinized Currently partial resection remains the preferred treatment modality although at diagnosis only approximately 20 of cases are amenable to this approach Post-partial resection the five-year survival rate is observed to be between 20-34 In cases of irresectability palliative chemotherapy often remains the only option typically associated with a poor prognosis Numerous studies have demonstrated that long-term outcomes following liver transplantation for iCCA have evolved and improved over the years In a meta-analysis by Ziogas et al data from a total of 18 studies involving 355 patients and one registry study 385 patients were analyzed The pooled 1- 3- and 5-year survival rates were 75 56 and 42 respectively Meanwhile the pooled 1- 3- and 5-year recurrence-free survival rates were 70 49 and 38 with an overall recurrence rate of 43 A potential reason for this marked improvement may be attributed to the introduction of neoadjuvant therapy Studies by Hu et al and Lunsford et al have demonstrated that the utilization of neoadjuvant therapy is associated with significantly improved survival outcomes The study aims to conduct a prospective non-randomized study LIVINCA to further explore the effects of living-donor liver transplantation in the treatment of unresectable neoadjuvant treated chemotherapy AND selective internal radiotherapy intrahepatic cholangiocarcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None