Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
NRU
Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
1 other identifier
interventional
12
1 country
1
Brief Summary
Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hepatocellular-carcinoma
Started May 2017
Shorter than P25 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedStudy Start
First participant enrolled
May 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2018
CompletedJune 12, 2018
June 1, 2018
1.5 years
April 23, 2017
June 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short term mortality rate
Percentage of patients' postoperative deaths
30 day
Secondary Outcomes (2)
Short term major complications' rate
30 days
Tumor response rate according to mRECIST criteria.
30 days
Study Arms (1)
Devascularization
EXPERIMENTALPatients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ribat University Hospital
Khartoum, 11111, Sudan
Related Publications (1)
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.
PMID: 31265917DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama M Elsanousi, MD
Faculty of Medicine. The National Ribat University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
April 23, 2017
First Posted
April 26, 2017
Study Start
May 20, 2017
Primary Completion
November 19, 2018
Study Completion
December 19, 2018
Last Updated
June 12, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- From June 2018 - December 2018
- Access Criteria
- Free