Hepatocellular carcinoma
Conditions
Interventions
Research group:Polyene phosphatidylcholine injection combined with magnesium isoglycyrrhizinate injection
Control group:Magnesium isoglycyrrhizinate injection monotherapy
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed as HCC by imaging and laboratory tests, and able to undergo laparoscopic anatomic resection. 2. Candidates for right or left hemihepatectomy; 3. During the surgery, the Pringle method was used to block the first hepatic portal, with each occlusion lasting 40%; 7. Single HCC, tumor diameter less than 10 cm, no distant metastasis or portal vein system involvement; 8. Preoperative ALT < 2xULN; 9. No prior treatment history before enrollment, such as portal vein embolization, TACE, or systemic anti-tumor drug treatment. 10. No use of liver damage treatment drugs within two weeks before enrollment;
Exclusion criteria
Exclusion criteria: 1. Liver vascular injury retention, including: reconstruction after cutting, ligation, embolization, thrombosis, etc. 2. Combined with coagulation dysfunction (PT prolonged by more than 3 seconds); 3. Combined obstructive jaundice, severe heart disease, severe kidney disease and other serious diseases; 4. Intraoperative use of microwave or combined microwave therapy; 5. The number of first hepatic gate blockades > 4 times, or single blockade time greater than 15 minutes; 6. Non-anatomic liver resection, where the remaining liver contains large areas of ischemia/stasis. 7. Intraoperative blood transfusion greater than 1000ml; 8. Intraoperative findings of extrahepatic disease, synchronous resection of organs other than the gallbladder is required. 9. Intraoperative findings of other intrahepatic lesions may require combination with other surgeries, such as ablation or choledochojejunostomy. 10. Previous diseases that have been treated with systemic glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system related diseases; 11. Patients with mental illness, severe neurosis, or inability to cooperate with the trial. 12. Participated in other clinical trials within 3 months before enrollment; 13. Allergic or intolerant to benzyl alcohol, investigational drug; 14. Pregnant and breastfeeding women; 15. Researchers believe that subjects with any other factors unsuitable for participating in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean ALT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean ALT;Mean values of AST, TBIL, ALP, and GGT; normalization rates of ALT, AST, and TBIL; and the proportion of patients with ALT < 120 U/L.;Incidence of postoperative complications, including pleural effusion, ascites (or intra-abdominal fluid collection), intra-abdominal hemorrhage, bile leak, and hepatic failure,Clavien-Dindo classifica; | — |
Countries
China
Contacts
Public ContactLianxin Liu
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
Outcome results
None listed