Liver Cirrhosis, Liver Neoplasms
Conditions
Keywords
Hepatocellular Carcinoma, Blood Loss, Haemorrhage, Vascular Control
Brief summary
This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.
Detailed description
Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.
Interventions
Infrahepatic inferior vena cava is clamped in hepatectomy.
PROCEDURESelective hepatic vascular exclusion
Selected major hepatic vein is clamped in hepatectomy.
PROCEDUREPortal triad clamping
Portal triad are clamped in hepatectomy.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. either male or female, older than 18 (include 18). 2. tumors oppress or be in close proximity to one or more of major hepatic veins. 3. the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit. 4. preoperative liver function assessment: Child-Pugh classification is A or B. 5. preoperative laboratory test: blood platlet count \> 100×10\^9/l, prothrombin activity \> 60%. 6. liver cirrhosis.
Exclusion criteria
1. contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system. 2. extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava. 3. hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach) 4. regular hepatectomy. 5. tumors located in the left lateral lobe of liver. 6. previous hepatectomy. 7. pregnancy or lactation. 8. refusal to participate this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | Intraoperative period | blood loss from incision to closure |
| Normalized transection-related blood loss | Intraoperative period | Intraoperative blood loss normalized by transection surface area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop of hemoglobin level | Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations) | — |
| Postrecovery of liver function | postoperative days 1, 3, 5, 7 | Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc. |
| Time of infrahepatic inferior vena cava or selected hepatic vein dissection | Intraoperative period | Time cost of dissection |
| Morbidity of postoperative complications | 90 days after surgery | — |
| Postoperative mortality | 90 days after surgery | — |
| Postrecovery of renal function | postoperative days 1, 3, 5, 7 | Renal function evaluation is composite of blood urea nitrogen, creatinine, etc. |
| Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure | Intraoperative period | — |
Countries
China
Contacts
Primary ContactXiaoping Chen, M.D.
Backup ContactChao Wu, M.M.
Outcome results
None listed