Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT03138031|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Non-resectable||Procedure: Percutaneous ethanol alcohol injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment. Prospective and non-randomized clinical trial|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||May 1, 2018|
|Estimated Study Completion Date :||May 30, 2018|
Experimental: Percutaneous Ethanol Injection (PEI)
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.
Procedure: Percutaneous ethanol alcohol injection
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.
- Overall survival rate [ Time Frame: 3 years ]The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
- Disease free survival [ Time Frame: 3 years ]Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.
- Major complications` rate [ Time Frame: 3 years ]Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
- Tumor response rate [ Time Frame: 3 years ]Mean percentage reduction in the sizes of the patients` tumors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138031
|Contact: Osama M Elsanousi, MD||+249 1222 firstname.lastname@example.org|
|Contact: Murtada A Mohamed, MD||+249 912 395 730|
|Ribat University Hospital||Recruiting|
|Khartoum, Sudan, 11111|
|Principal Investigator:||Murtada A Mohamed, MD||Ribat University Hospital|
|Study Chair:||Osama M Elsanousi, MD||The National Ribat University|