Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma (NRU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03129685
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : June 12, 2018
Information provided by (Responsible Party):
Osama Mohamed Elsanousi, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: HALED Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective 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
Estimated Primary Completion Date : November 19, 2018
Estimated Study Completion Date : December 19, 2018

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.

Primary Outcome Measures :
  1. Short term mortality rate [ Time Frame: 30 day ]
    Percentage of patients` postoperative deaths

Secondary Outcome Measures :
  1. Short term major complications` rate [ Time Frame: 30 days ]
    Incidence of Clavien/Dindo grade 3 or more postoperative complications

  2. Tumor response rate according to mRECIST criteria. [ Time Frame: 30 days ]
    Estimation of the residual percentage of viable tumor following the devascularization.

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03129685

Contact: Osama M Elsanousi, MD +249 1222 29574

Ribat University Hospital Recruiting
Khartoum, Sudan, 11111
Sponsors and Collaborators
The National Ribat University
Principal Investigator: Osama M Elsanousi, MD Faculty of Medicine. The National Ribat University

Responsible Party: Osama Mohamed Elsanousi, Associate Professor of Surgery, The National Ribat University Identifier: NCT03129685     History of Changes
Other Study ID Numbers: IS-001-17
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From June 2018 - December 2018
Access Criteria: Free

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osama Mohamed Elsanousi, The National Ribat University:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases