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Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: 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 (PAT or PEI) for the large and inoperable hepatocellular carcinoma. 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 |
|---|---|---|---|
| Percutaneous Ethanol Injection (PEI) | Experimental | Those participants receive percutaneous ethanol alcohol injection for the large and unresectable HCC. Absolute alcohol; weekly sessions; under close monitoring; maximum of 30 mls; no anaesthesia needed and a maximum pain score of "8" during the procedure. Postprocedure analgesia may be required. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous ethanol alcohol injection | Procedure | Day-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of "8" limits the procedure. Post-procedure analgesia may be required. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | The percentage of HCC patients who are still alive for three years after they started PEI for 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 PEI. | 3 years |
| Major complications' rate | Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama M Elsanousi, MD | The National Ribat University | Principal Investigator |
| Murtada M Mohamed, MD | Ribat University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ribat University Hospital | Khartoum | 11111 | Sudan |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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Single Group Assignment. Prospective and non-randomized clinical trial
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No masking
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| 3 years |
| Tumor response rate | Mean percentage reduction in the sizes of the patients' tumors | 3 years |
| D013812 |
| Therapeutics |