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

The National Ribat University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Combined Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03138044

IS-003-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Combined Treatment

Experimental group

Description:

The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions.

Treatment:

Procedure: Combined Treatment