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poor recruitment and an unexpected low treatment rate
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The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative aTARE | Experimental | The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirsphere trans-arterial radioembolization | Device | Patients will receive Sirsphere trans-arterial radioembolization before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative morbidity | peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days) | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Assessment of the overall disease free survival and Overall Survival | 3 years |
| One and three years survival | Estimation of disease free survival and overall survival rates after 1 and 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Hendlisz, MD | Jules Bordet Institute | Principal Investigator |
| Vincent Donckier, MD, PHD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium | |||
| Erasme Hosptial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29486918 | Derived | Lemaire M, Lucidi V, Bouazza F, Katsanos G, Vanderlinden B, Levillain H, Delatte P, Garcia CA, Vouche M, Galdon MG, Demetter P, Deleporte A, Hendlisz A, Flamen P, Donckier V. Selective internal radiation therapy (SIRT) before partial hepatectomy or radiofrequency destruction for treatment of hepatocellular carcinoma in cirrhotic patients: a feasibility and safety pilot study. HPB (Oxford). 2018 Jul;20(7):641-648. doi: 10.1016/j.hpb.2018.01.006. Epub 2018 Feb 24. |
| Label | URL |
|---|---|
| Jules Bordet Institute | View source |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| one and three years |
| Tumor regression | Assessment of tumour size regression after Trans-arterial radioembolization by MRI | 8 weeks after Trans-arterial radioembolization |
| Functional Imaging | Assessment of imaging parameters changes (DW-MRI, FDG-PET/CT) and MAA-SPECT-CT in relation to the outcome measured by tumour regression after TARE, disease free and overall survival. | 3 years |
| Contra-lateral Lobe Hypertrophy | Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI). | 3 Years |
| Brussels |
| 1070 |
| Belgium |
| Erasme Hospital | View source |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |