Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: HALED

• Registration Number: NCT03129685
• Lead Sponsor: The National Ribat University

Brief Summary

Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.

Detailed Description

Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.

Study Timeline

• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Study Start: 2017-05-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-08
• Last Update Posted: 2018-06-12
• Primary Completion: 2018-11-19
• Study Completion: 2018-12-19

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 thrombocytopenia;
• Unable or unwilling to attend follow up visits and examinations;
• Other associated surgical procedure;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Devascularization	HALED	Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)

Primary Outcome Measures

Name	Time	Method
Short term mortality rate	30 day	Percentage of patients' postoperative deaths

Secondary Outcome Measures

Name	Time	Method
Tumor response rate according to mRECIST criteria.	30 days	Estimation of the residual percentage of viable tumor following the devascularization.
Short term major complications' rate	30 days	Incidence of Clavien/Dindo grade 3 or more postoperative complications

Trial Locations

Locations (1)

Ribat University Hospital; 🇸🇩 Khartoum, Sudan