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Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03138044
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 combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Combined Treatment 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 Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. 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 : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-randomized and time series clinical trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Combined Treatment
The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions.
Procedure: Combined Treatment
This modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive.
Other Name: CILDAT




Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 3 years ]
    The percentage of patients who are still alive for three years after they started CILDAT for their large 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 CILDAT

  2. Major complications` rate [ Time Frame: 3 years ]
    Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.

  3. Major toxicity rate [ Time Frame: 3 years ]
    Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade

  4. 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 75 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 uncorrectable thrombocytopenia;
  • Unable or unwilling to attend follow up visits and examinations;

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): NCT03138044


Contacts
Contact: Osama M Elsanousi, MD +249 1222 29574 osamagreen55@gmail.com

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

Responsible Party: Osama Mohamed Elsanousi, General Surgeon, The National Ribat University
ClinicalTrials.gov Identifier: NCT03138044     History of Changes
Other Study ID Numbers: IS-003-17
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:
Hepatocellular Carcinoma
Ipsilateral Liver Lobe Devascularization
Alcohol Treatment
CILDAT

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