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Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma Non-resectable

Status
Completed
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
Percutaneous ethanol alcohol injection
Sponsored by
The National Ribat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Percutaneuos Ethanol alcohol injection

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Ribat University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Percutaneous Ethanol Injection (PEI)

Arm 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.

Outcomes

Primary Outcome Measures

Overall survival rate
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2017
Last Updated
May 11, 2019
Sponsor
The National Ribat University
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1. Study Identification

Unique Protocol Identification Number
NCT03138031
Brief Title
Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma
Official Title
Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Ribat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-resectable
Keywords
Percutaneuos Ethanol alcohol injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment. Prospective and non-randomized clinical trial
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Ethanol Injection (PEI)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous ethanol alcohol injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival rate
Description
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.
Time Frame
3 years
Title
Major complications' rate
Description
Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
Time Frame
3 years
Title
Tumor response rate
Description
Mean percentage reduction in the sizes of the patients' tumors
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama M Elsanousi, MD
Organizational Affiliation
The National Ribat University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murtada M Mohamed, MD
Organizational Affiliation
Ribat University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribat University Hospital
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

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