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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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Transplant | Experimental | The patients will be transplanted according to standard procedures by the institutional protocol. The transplantation procedure is initiated by an exploratory laparotomy with clinical assessment and frozen section of the lymphnodes in the hepatoduodenal ligament and along the common hepatic artery/coeliac axis. Evidence of disease dissemination to these regional lymph nodes will be an absolute contraindication to transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Transplant | Procedure | Liver Transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome | From screening and until 36 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival from time of relapse | OS as assessed by QLQ-C30 patient reported outcome | From time of relapse and until 36 months after inclusion |
| Disease free survival | CT-scan/MRI scan according to RECISTcriteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magnus Smedman, MD | Contact | 23026600 | +47 | torha@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Magnus Smedman, MD | Oslo University Hospital | Principal Investigator |
| Sheraz Yaqub, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 0451 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38258823 | Derived | Achurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23. |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| After liver transplantation and up 10 years after liver transplantation |
| Start of new treatment/Change of strategy | Time to start of new treatment | Immediately after liver transplatation to start of new treatment |
| Time to decrease in physical function and global health score | Quality of life measured by EORTC QLQ-C30), | Up to 10 years after liver transplantation |
| Liver transplant Complication | Number of Clavien-Dindo grad 3-5 complications | Up to 90 days after liver transplantation |
| Number of Participants Developing other Malignancies | Diagnosis of other malignancies | Up to 10 years after liver transplantation |
| Survival in relation to biological markers | CEA, CA 19-9 and Germline DNA analyses | After Liver Transplant until 10 years after liver transplantation |
| D009369 | Neoplasms |
| D013505 |
| Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |