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

Hepatocellular Carcinoma Clinical Trial

Official title:

Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03138044
• Other study ID #: IS-003-17
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2019
• Source: The National Ribat University
• Contact: Osama M Elsanousi, MD
• Phone: +249 1222 29574
• Email: osamagreen55[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Sudan	Ribat University Hospital	Khartoum

Sponsors (1)

Lead Sponsor	Collaborator
The National Ribat University

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	The percentage of patients who are still alive for three years after they started CILDAT for their large HCC.	3 years
Secondary	Disease free survival	Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after CILDAT	3 years
Secondary	Major complications` rate	Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.	3 years
Secondary	Major toxicity rate	Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade	3 years
Secondary	Tumor response rate	Mean percentage reduction in the sizes of the patients` tumors	3 years