Hepatocellular carcinoma
Conditions
Interventions
New drug delivery group:After ligating the target liver segment's portal vein, use a new ICG formulation (add 0.5 mg of ICG powder and 500 mg of human albumin to 20 ml of saline, shake well and let st
ICG 0.025 mg/ml, human albumin 25 mg/ml). Finally, administer it continuously via peripheral intravenous infusion at a rate of 1 ml/min. Stop the infusion when clear fluorescence imaging appears in th
Guideline Recommended Group:After ligating the target liver segment's portal vein, administer 2.5mg of ICG (2.5mg/ml) intravenously via a peripheral blood vessel.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, patients with malignant liver tumors requiring laparoscopic anatomical liver resection, including hepatocellular carcinoma, cholangiocarcinoma, and mixed cell carcinoma. 2. Preoperative liver function Child-Pugh grade A or B; 3. No contraindications for laparoscopic liver resection; 4. Expected survival >= 3 months; 5. ECOG PS score 0-1; 6. Major organ functions are normal, and laboratory test results within 7 days prior to enrollment meet the following criteria: white blood cells (WBC) >= 2.5×10^9/L, absolute neutrophil count (ANC) >= 1.5×10^9/L, platelets (PLT) >= 75×10^9/L, hemoglobin (HGB) >= 90 g/L; NR <= 1.5xULN; serum creatinine (CT) <= 1.5xULN; total bilirubin (TBI) <= 1.5× the upper limit of normal (ULN); 7. The patient voluntarily agrees to participate and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. During surgery, if there is no obvious ischemic line after blocking or isolating the target hepatic pedicle, or if the liver fluorescence reaches a level that interferes with the operation before intravenous ICG injection. 2. Poor liver reserve function (ICG R15 >= 20%); 3. Severe heart or lung disease that prevents tolerance of general anesthesia; 4. Moderate or larger amounts of pleural or abdominal effusion with clinical symptoms; 5. Active bleeding or coagulation disorders; 6. Hepatic encephalopathy; 7. Allergy to ICG; 8. History of gastrointestinal bleeding within the past 6 months or a clear tendency for gastrointestinal bleeding; 9. Severe gastric fundus or esophageal varices requiring interventional treatment; 10. Objective evidence of past or current pulmonary fibrosis or severely impaired lung function; 11. Any significant clinical or laboratory abnormalities that the investigator believes could affect safety evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescence imaging effect; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time;Surgical blood loss;Conversion;Liver parenchyma transection time;Number of hemostatic clips used on the liver section;Tumor margin;Postoperative complications;Postoperative liver function status;Postoperative intestinal function recovery time;Postoperative hospital stay;Overall survival time;Time without disease recurrence;Progression-free survival time;Distant metastasis-free survival time; | — |
Countries
China
Contacts
Public ContactFengwei Gao
West China Hospital of Sichuan University
Outcome results
None listed