Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

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

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: HALED


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective and non-randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Devascularization<br>Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED) | Procedure: HALED<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Devascularization