NCT06539377Not yet recruiting
Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma
Living Donor Liver Transplantation for Neoadjuvant Treated, Unresectable Intrahepatic Cholangiocarcinoma
Source: ClinicalTrials.gov · Last updated 6 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Oct 2030
- Lead sponsor
- Jena University Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06539377
What you commit to
- Study type: Interventional
- Planned participants: 6
- From 1 Sept 2024 to the primary completion date, 1 Oct 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- general contraindications for liver transplantation
Other
- extrahepatic tumor/metastases
- G3 tumors
- progress under neoadjuvant treatment according to the RECIST-criteria
- pregnancy or breastfeeding
- patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
Who the study is looking for
- 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
- peritoneal carcinosis / extrahepatic spread ruled out in PET-CT and/or MRT/CT and, at latest, during exploration
- age ≥ 18
- blood-group compatible living donor available
- in female patients: negative pregnancy test
- written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.