Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Radiologically strong suspicion of pCCA
Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein
Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery
First time pCCA
Disqualifiers
Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor
Tumor involving main portal vein
Tumor involving inferior vena cava
Perforation of the visceral peritoneum
Trial design
Design model
Single group
Treatments tested in this trial
Liver transplant
Procedure/SurgeryLiver transplant.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Liver transplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
Patient record
Time frame
From screening and until 36 months after inclusionSecondary outcomes
1
Overall survival from time of relapse
Patient record
Time frame
From time of relapse and until 36 months after inclusion2
Disease free survival
CT-scan/MRI scan according to RECISTcriteria
Time frame
After liver transplantation and up 10 years after liver transplantation3
Time to start of new treatment/change in strategy
Patient record
Time frame
Immediately after liver transplatation to start of new treatment4
Quality of life (EORTC QLQ-C30), time to decrease in physical function and global health score
Quality of life measured by EORTC QLQ-C30
Time frame
Up to 10 years after liver transplantationSponsors and contacts
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Source ClinicalTrials.gov