Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, Devascularization
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.
Interventions
PROCEDUREHALED
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.
Sponsors
The National Ribat University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective and non-randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term mortality rate | 30 day | Percentage of patients' postoperative deaths |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sudan
Contacts
Primary ContactOsama M Elsanousi, MD
Outcome results
None listed