Health TrialsbyHealthPanel

Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma

ConditionsLiving Donor Liver TransplantationLiver TransplantationNeoadjuvant Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJena University Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

non-resectable intrahepatic cholangiocarcinoma (either for localization / distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis / cirrhosis)

biopsy proven grading G1 / G2

in case of mixed hepatocellular carcinoma / cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 / G2

response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory

Disqualifiers

extrahepatic tumor/metastases

G3 tumors

progress under neoadjuvant treatment according to the RECIST-criteria

pregnancy or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

  • Living donor liver transplantation

    Procedure/Surgery

    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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Living donor liver transplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Five year overall survival

Survival from time of transplantation to time of death or last follow up

Time frame
Five years

Secondary outcomes

1

Recurrence-free survival

Survival from time of transplantation to time of death or first evidence of recurrence to disease

Time frame
Five years
2

Donor and Recipient morbidity

Donor and Recipient morbidity (both according to the Clavien-Dindo classification)

Time frame
Five years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jena University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: