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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
HALED
Sponsored by
The National Ribat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Devascularization

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Ribat University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Devascularization

Arm Description

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

Outcomes

Primary Outcome Measures

Short term mortality rate
Percentage of patients' postoperative deaths

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2017
Last Updated
June 8, 2018
Sponsor
The National Ribat University
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1. Study Identification

Unique Protocol Identification Number
NCT03129685
Brief Title
Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
Acronym
NRU
Official Title
Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
November 19, 2018 (Anticipated)
Study Completion Date
December 19, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Ribat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Devascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective and non-randomized clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Devascularization
Arm Type
Experimental
Arm Description
Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)
Intervention Type
Procedure
Intervention Name(s)
HALED
Intervention Description
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 Measure Information:
Title
Short term mortality rate
Description
Percentage of patients' postoperative deaths
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Short term major complications' rate
Description
Incidence of Clavien/Dindo grade 3 or more postoperative complications
Time Frame
30 days
Title
Tumor response rate according to mRECIST criteria.
Description
Estimation of the residual percentage of viable tumor following the devascularization.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama M Elsanousi, MD
Phone
+249 1222 29574
Email
osamagreen55@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama M Elsanousi, MD
Organizational Affiliation
Faculty of Medicine. The National Ribat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribat University Hospital
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
From June 2018 - December 2018
IPD Sharing Access Criteria
Free
Citations:
PubMed Identifier
31265917
Citation
Elsanousi OM, Mohamed MA, Salim FH, Adam EA. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg. 2019 Aug;68:134-141. doi: 10.1016/j.ijsu.2019.06.014. Epub 2019 Jun 29.
Results Reference
derived

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Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

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