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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Combined Treatment

• Registration Number: NCT03138044
• Lead Sponsor: The National Ribat University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-04-30
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Study Start: 2017-05-20
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-11
• Last Update Posted: 2019-05-14
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined Treatment	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.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	3 years	The percentage of patients who are still alive for three years after they started CILDAT for their large HCC.

Secondary Outcome Measures

Name	Time	Method
Disease free survival	3 years	Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after CILDAT
Major complications' rate	3 years	Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.
Major toxicity rate	3 years	Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
Tumor response rate	3 years	Mean percentage reduction in the sizes of the patients' tumors

Trial Locations

Locations (1)

Ribat University Hospital; 🇸🇩 Khartoum, Sudan