Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03138044|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: Combined Treatment||Not Applicable|
|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)|
|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|
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
- 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.
- 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
- Major complications` rate [ Time Frame: 3 years ]Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.
- Major toxicity rate [ Time Frame: 3 years ]Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
- Tumor response rate [ Time Frame: 3 years ]Mean percentage reduction in the sizes of the patients` tumors
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
|Contact: Osama M Elsanousi, MD||+249 1222 firstname.lastname@example.org|
|Ribat University Hospital||Recruiting|
|Khartoum, Sudan, 11111|
|Principal Investigator:||Osama M Elsanousi, MD||The National Ribat University|