Liver cancer Cancer Malignant neoplasm of liver and intrahepatic bile ducts
Conditions
Interventions
Method of randomization:
Randomization Method: RAR
The randomize R package of version 1.4 was used for generating the randomization list with the R version 3.4.0. This
Sponsors
Centro Hospitalar Universitário Lisboa Central
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of primary or secondary malignant tumours of the liver, documented by computed tomography or magnetic resonance imaging or biopsy of the tumor lesion 2. Indication for resection of the hepatic tumor 3. An estimated future liver remnant (FLR) less than: 3.1. 25% in healthy liver 3.2. 40% in cirrhotic liver or with severe steatosis or previous chemotherapy 4. Renal function suitable for the use of iodinated venous contrast medium: 4.1. Serum creatinine = 1.4 mg/dL 4.2. Clearance of creatinine (GFR) = 60 mL/min/1.73m2 5. Age = 18 years
Exclusion criteria
Exclusion criteria: 1. Uncorrectable coagulopathies 2. Sectorial portal thrombosis (e.g., thrombosis of the right anterior sectorial branch)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic hypertrophy (liver volume growth) measured by computed tomography volumetry at 14 and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fluoroscopy time (total minutes; e.g. 15 minutes of fluoroscopy), provided automatically by the Angiography machine at the end of each procedure (at the end of Portal Vein Embolization) 2. Contrast volume (millilitres), noted at the end of each procedure (at the end of Portal Vein Embolization) 3. Portal Vein Embolization execution total time (minutes), from the moment the Interventional Radiologist first punctures the liver up to the moment right after removing the liver access sheath 4. Postoperative outcome after liver surgery: this is a composite secondary endpoint: 4.1. Post-operative total hospitalization time (days) from the day of the liver surgery up to hospital discharge 4.2. Length of stay in the intensive care unit (days) from the day of the liver surgery up to intensive care unit discharge 4.3. Use of the "ISGLS" criteria (Rahbari et al Surgery 2011;149(5): 713–724) for liver failure evaluation 4.4. Occurrence of patient death up to 60 days after liver surgery (days) from liver surgery up to 60 days Original secondary outcome measure at submission: In the registry text, the "50-50" criteria was incorrectly attributed as the criteria to evaluate liver failure, being corrected to the "ISGLS" criteria, as in the original protocol (version 1.3). | — |
Countries
Portugal
Contacts
Public ContactJose Hugo Luz
Outcome results
None listed