Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Overall survival rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No masking
Eligibility Criteria
- Ages
- 15 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
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.
Intervention: Percutaneous ethanol alcohol injection (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Disease free survival(3 years)
- Tumor response rate(3 years)
- Major complications' rate(3 years)
Investigators
Osama Mohamed Elsanousi
General Surgeon
The National Ribat University