Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— NRU  

Official title:

Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129685
• Other study ID #: IS-001-17
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: December 19, 2018

Study information

• Verified date: June 2018
• 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 short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 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 thrombocytopenia;

• Unable or unwilling to attend follow up visits and examinations;

• Other associated surgical procedure;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• HALED
This is attained via a laparotomy involves isolation of the arterial blood supply of the tumor-containing liver lobe (the ipsilateral hepatic artery as well as the extrahepatic arterial collaterals) while preserving the feeding veins.

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	Short term mortality rate	Percentage of patients` postoperative deaths	30 day
Secondary	Short term major complications` rate	Incidence of Clavien/Dindo grade 3 or more postoperative complications	30 days
Secondary	Tumor response rate according to mRECIST criteria.	Estimation of the residual percentage of viable tumor following the devascularization.	30 days