Liver Cancer, Surgery
Conditions
Keywords
liver resection, blood inflow control, ischemia-reperfusion injury, inflammatory response, randomized controlled trial
Brief summary
The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.
Detailed description
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.
Interventions
PROCEDUREnon-occlusion technique
Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A; 2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy; 3. Tumors located either in the left or right hemiliver; 4. Resection extent was a hemi-hepatectomy or less; 5. Informed consent.
Exclusion criteria
1. Having comorbidity that contraindicates surgery; 2. Participation in concurrent interventional trials with interference to this study; 3. Eligible for laparoscopic hepatectomy; 4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction; 5. Lack of compliance for treatment or future follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum total bilirubin on postoperative day 5 | 5 days | Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of blood transfusion | Entire operation duration | The amount of intraoperative blood transfusion |
| Operative time | Entire operation duration | The time from induction of anesthesia to the closure of abdomen |
| Postoperative intensive-care unit (ICU) stay | Duration of stay in ICU | Duration of stay in ICU |
| Hospital stay | Duration of hospital stay | Duration of hospital stay |
| Intraoperative blood loss | Entire operation duration | Total blood loss from the incision to the closure of abdomen |
| Perioperative systemic inflammatory response | an expected average of 7 days | 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. |
| Postoperative morbi-mortality | an expected average of 12 days in hospital | Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality |
| Long-term oncologic outcomes | 5 years after operation | 1, 3, 5-year tumor recurrence rate |
| Long-term survival | 5 years after operation | 1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS) |
| Total hospital expenditure | Duration of hospital stay | Total costs during hospital stay |
Countries
China
Contacts
Primary ContactShichun Lu, MD, PhD
Backup ContactYinzhe Xu, MD, PhD
Outcome results
None listed