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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03138044 |
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Date of registration:
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30/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma
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Scientific title:
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Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC) |
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Date of first enrolment:
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May 20, 2017 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03138044 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sudan
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Contacts
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Name:
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Osama M Elsanousi, MD |
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Address:
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Telephone:
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+249 1222 29574 |
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Email:
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osamagreen55@gmail.com |
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Affiliation:
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Name:
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Osama M Elsanousi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The National Ribat University |
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Key inclusion & exclusion criteria
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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;
Age minimum:
15 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Procedure: Combined Treatment
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Primary Outcome(s)
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Overall survival rate
[Time Frame: 3 years]
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Secondary Outcome(s)
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Tumor response rate
[Time Frame: 3 years]
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Disease free survival
[Time Frame: 3 years]
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Major complications' rate
[Time Frame: 3 years]
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Major toxicity rate
[Time Frame: 3 years]
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Secondary ID(s)
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IS-003-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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