Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.

Conditions
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Hepatocellular Carcinoma Non-resectable

Intervention / Treatment
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* Procedure: Percutaneous ethanol alcohol injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Review and sign informed consent; Between 15 and 80 years of age at time of trial enrollment; Documented pathological and/or radiological diagnosis of hepatocellular carcinoma; Radiologically documented tumor size of > 5 centimeters; Radiologically documented liver cirrhosis. Exclusion Criteria: American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia; Uncontrollable ascites; Deep persistent jaundice; Hepatic encephalopathy; Coagulopathy; Severe thrombocytopenia; Unable or unwilling to attend follow up visits and examinations; Other associated surgical procedure;

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment. Prospective and non-randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Ethanol Injection (PEI)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 years | 
| Tumor response rate | Mean percentage reduction in the sizes of the patients' tumors | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneuos Ethanol alcohol injection