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Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.
Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Treatment | Experimental | The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Treatment | Procedure | This modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | The percentage of patients who are still alive for three years after they started CILDAT for their large HCC. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after CILDAT | 3 years |
| Major complications' rate | Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osama M Elsanousi, MD | Contact | +249 1222 29574 | osamagreen55@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Osama M Elsanousi, MD | The National Ribat University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ribat University Hospital | Recruiting | Khartoum | 11111 | Sudan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34888043 | Derived | Elsanousi OM, Mohamed MA, Salim FH, Adam EA, Bedri S. Long-term outcome of novel combined surgical-injection treatment (COSIT) for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Ann Med Surg (Lond). 2021 Nov 24;72:103098. doi: 10.1016/j.amsu.2021.103098. eCollection 2021 Dec. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Prospective, non-randomized and time series clinical trial.
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|
| 3 years |
| Major toxicity rate | Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade | 3 years |
| Tumor response rate | Mean percentage reduction in the sizes of the patients' tumors | 3 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |