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

June 8, 2018 updated by: Osama Mohamed Elsanousi, The National Ribat University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Khartoum, Sudan, 11111
        • Recruiting
        • Ribat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term mortality rate
Time Frame: 30 day
Percentage of patients' postoperative deaths
30 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The National Ribat University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2017

Primary Completion (Anticipated)

November 19, 2018

Study Completion (Anticipated)

December 19, 2018

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS-001-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

From June 2018 - December 2018

IPD Sharing Access Criteria

Free

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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