Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

May 11, 2019 updated by: Osama Mohamed Elsanousi, The National Ribat University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Khartoum, Sudan, 11111
        • Ribat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 3 years
Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.
3 years
Major complications' rate
Time Frame: 3 years
Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
3 years
Tumor response rate
Time Frame: 3 years
Mean percentage reduction in the sizes of the patients' tumors
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The National Ribat University

Investigators

  • Principal Investigator: Murtada M Mohamed, MD, Ribat University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 30, 2018

Study Registration Dates

First Submitted

April 30, 2017

First Submitted That Met QC Criteria

April 30, 2017

First Posted (ACTUAL)

May 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 11, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS-002-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma Non-resectable

Clinical Trials on Percutaneous ethanol alcohol injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe