Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

The National Ribat University

Status: Completed

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Procedure: Percutaneous ethanol alcohol injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03138031

IS-002-17

Details and patient eligibility

About

Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Percutaneous Ethanol Injection (PEI)

Experimental group

Description:

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.

Treatment:

Procedure: Percutaneous ethanol alcohol injection