Trial Information
Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
Inclusion Criteria:
- Age >18
- Child's A or B cirrhosis
Exclusion Criteria:
- Informed consent not available
- Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal
vein embolisation
- Presence of hepatic artery thrombosis, previous transarterial therapy like TACE,
lipiodol-ethanol mixture injection or transarterial internal radiation
- Anticipation of portal vein resection
- Emergency hepatectomy
- Ruptured HCC
- Adhesion or anatomical variation that preclude safe and successful application of
Pringle maneuver
- Anticipation of concomitant bowel or bile duct resection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Post-operative surgical complications
Outcome Description:
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
Outcome Time Frame:
1 month
Safety Issue:
Yes
Principal Investigator
Kit Fai Lee, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinical Associate Professor (honorary)
Authority:
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study ID:
CRE-2012.351-T
NCT ID:
NCT01759901
Start Date:
January 2013
Completion Date:
February 2015
Related Keywords:
- Hepatocellular Carcinoma
- hepatectomy
- vascular inflow occlusion
- Carcinoma
- Carcinoma, Hepatocellular