Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138031
• Other study ID #: IS-002-17
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: September 2017
• Source: The National Ribat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 30, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

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.

Locations

Country	Name	City	State
Sudan	Ribat University Hospital	Khartoum

Sponsors (1)

Lead Sponsor	Collaborator
The National Ribat University

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	The percentage of HCC patients who are still alive for three years after they started PEI for HCC.	3 years
Secondary	Disease free survival	Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.	3 years
Secondary	Major complications` rate	Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade	3 years
Secondary	Tumor response rate	Mean percentage reduction in the sizes of the patients` tumors	3 years