An interventional study of Living donor liver transplantation in Living Donor Liver Transplantation, Liver Transplantation and Neoadjuvant Therapy, sponsored by Jena University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Jena University Hospital · Not applicable, Interventional, and Treatment
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).
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.
930 studies on the registry are indexed under Cholangiocarcinoma; 292 are open to participants now.
This study's planned enrollment of 6 is below the median of 50 across 698 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
The evaluation tests prior the transplantation will be performed following the standard protocol for the evaluation of a waiting list applicants prior liver transplantation. The aim of this procedure is to rule out any significant co-morbidities (e.g. cardiologic diseases, other malignancies) which would preclude liver transplantation. After successful evaluation of the recipient and waiting list registration with Eurotransplant, the AB0-compatible donor will be evaluated as well according to a center-specific protocol. For a local control of the tumor, an additional local-ablative therapy (SIRT) is mandatory.
Procedure: Living donor liver transplantation
Liver transplantation from living donor donation (SII/III as left-lateral donation during a "two stage"-procedure or left lobe donation or right lobe donation) in patients with unresectable intrahepatic cholangiocarcinoma.
Five year overall survival
Survival from time of transplantation to time of death or last follow up
Time frame: Five years
Recurrence-free survival
Survival from time of transplantation to time of death or first evidence of recurrence to disease
Time frame: Five years
Donor and Recipient morbidity
Donor and Recipient morbidity (both according to the Clavien-Dindo classification)
Time frame: Five years
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2024; primary completion for Oct 2030, 73 months later.
Of 78 non-industry interventional studies with no phase under Cholangiocarcinoma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28. This study's planned 73 months is above that.
Counting every sponsor, half of 79 studies reached it within 46 months; a quarter within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Jena University Hospital