An interventional study of Percutaneous ethanol alcohol injection in Hepatocellular Carcinoma Non-resectable, sponsored by The National Ribat University. Completed at 1 site in Sudan. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by The National Ribat University · Not applicable, Interventional, and Treatment
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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's enrollment of 23 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →The National Ribat University is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
Time frame: 3 years
Disease free survival
Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.
Time frame: 3 years
Major complications' rate
Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
Time frame: 3 years
Tumor response rate
Mean percentage reduction in the sizes of the patients' tumors
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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The National Ribat University