The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.
High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion. This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis. This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSerum total bilirubin on postoperative day 5
Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.
Time frame: 5 days
Intraoperative blood loss
Total blood loss from the incision to the closure of abdomen
Time frame: Entire operation duration
Requirement of blood transfusion
The amount of intraoperative blood transfusion
Time frame: Entire operation duration
Operative time
The time from induction of anesthesia to the closure of abdomen
Time frame: Entire operation duration
Postoperative intensive-care unit (ICU) stay
Duration of stay in ICU
Time frame: Duration of stay in ICU
Hospital stay
Duration of hospital stay
Time frame: Duration of hospital stay
Total hospital expenditure
Total costs during hospital stay
Time frame: Duration of hospital stay
Perioperative systemic inflammatory response
Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-α (TNF-α), interleukins (IL)-1α, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points.
Time frame: an expected average of 7 days
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Postoperative morbi-mortality
Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality
Time frame: an expected average of 12 days in hospital
Long-term oncologic outcomes
1, 3, 5-year tumor recurrence rate
Time frame: 5 years after operation
Long-term survival
1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)
Time frame: 5 years after operation