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Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03138031
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Osama Mohamed Elsanousi, The National Ribat University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Non-resectable Procedure: Percutaneous ethanol alcohol injection Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment. Prospective and non-randomized clinical trial
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 30, 2018

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Major complications` rate [ Time Frame: 3 years ]
    Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade

  3. Tumor response rate [ Time Frame: 3 years ]
    Mean percentage reduction in the sizes of the patients` tumors



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138031


Contacts
Contact: Osama M Elsanousi, MD +249 1222 29574 osamagreen55@gmail.com
Contact: Murtada A Mohamed, MD +249 912 395 730

Locations
Sudan
Ribat University Hospital Recruiting
Khartoum, Sudan, 11111
Sponsors and Collaborators
The National Ribat University
Investigators
Principal Investigator: Murtada A Mohamed, MD Ribat University Hospital
Study Chair: Osama M Elsanousi, MD The National Ribat University

Responsible Party: Osama Mohamed Elsanousi, General Surgeon, The National Ribat University
ClinicalTrials.gov Identifier: NCT03138031     History of Changes
Other Study ID Numbers: IS-002-17
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osama Mohamed Elsanousi, The National Ribat University:
Percutaneuos Ethanol alcohol injection

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs