NRU: Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

Sponsor

The National Ribat University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03129685

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: HALED	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective and non-randomized clinical trialProspective and non-randomized clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2017

Anticipated Primary Completion Date :

Nov 19, 2018

Anticipated Study Completion Date :

Dec 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Devascularization Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)	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.

Arm

Intervention/Treatment

Experimental: Devascularization

Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)

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.

Outcome Measures

Primary Outcome Measures

Short term mortality rate [30 day]
Percentage of patients' postoperative deaths

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ribat University Hospital	Khartoum		Sudan	11111

Sponsors and Collaborators

The National Ribat University

Investigators

Principal Investigator: Osama M Elsanousi, MD, Faculty of Medicine. The National Ribat University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Osama Mohamed Elsanousi, Associate Professor of Surgery, The National Ribat University

ClinicalTrials.gov Identifier:

NCT03129685

Other Study ID Numbers:

IS-001-17

First Posted:

Apr 26, 2017

Last Update Posted:

Jun 12, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Osama Mohamed Elsanousi, Associate Professor of Surgery, The National Ribat University

Hepatocellular carcinoma

Devascularization

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jun 12, 2018