Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

NCT ID: NCT03138031

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-05-30

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Percutaneous ethanol alcohol injection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The National Ribat University

OTHER

Sponsor Role: lead

Responsible Party

Osama Mohamed Elsanousi

General Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama M Elsanousi, MD

Role: PRINCIPAL_INVESTIGATOR

The National Ribat University

Murtada M Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

Ribat University Hospital

Locations

Ribat University Hospital

Khartoum, , Sudan

Countries

Sudan

Other Identifiers

IS-002-17

Identifier Type: -

Identifier Source: org_study_id