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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: |
NCT03138031 |
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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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Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma
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Scientific title:
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Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma. |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03138031 |
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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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Murtada M Mohamed, 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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Ribat University Hospital |
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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 thrombocytopenia;
- Unable or unwilling to attend follow up visits and examinations;
- Other associated surgical procedure;
Age minimum:
15 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma Non-resectable
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Intervention(s)
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Procedure: Percutaneous ethanol alcohol injection
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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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Major complications' rate
[Time Frame: 3 years]
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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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Secondary ID(s)
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IS-002-17
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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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