Hepatic malignant tumor
Conditions
Interventions
Experimental group (novel ICG@HSA administration group):After ligation of the target hepatic segmental portal vein, the novel ICG regimen (0.5 mg ICG powder and 500 mg human serum albumin added to 20
Control group (guideline-recommended ICG administration group).:After ligation of the target hepatic segmental portal vein, 2.5 mg of ICG (2.5 mg/ml) was intravenously injected.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old, patients with hepatic malignancies who are undergoing laparoscopic anatomical liver resection; (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) Normal major organ functions, and meet the following laboratory test results within 7 days prior to enrollment: white blood cell (WBC) =2.5×10^9/L, absolute neutrophil count (ANC) =1.5×10^9/L, platelet (PLT) =75×10^9/L, hemoglobin (HGB) =90g/L; NR =1.5xULN; serum creatinine (CT) =1.5xULN; total bilirubin (TBI) =1.5×upper limit of normal (ULN); (7) Patients voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) No obvious ischemic demarcation line after intraoperative occlusion or disconnection of target hepatic pedicle, or the liver fluorescence reaches an intensity that interferes with surgery before intraoperative ICG injection. (2) Poor hepatic reserve function (ICG R15 = 20%); (3) Severe cardiopulmonary diseases, intolerant to general anesthesia and surgery; (4) Moderate or large amount of symptomatic ascites or pleural effusion; (5) Active bleeding or coagulation abnormalities; (6) Hepatic encephalopathy; (7) Allergy to ICG; (8) History of gastrointestinal bleeding within the past 6 months or definite tendency for gastrointestinal bleeding; (9) Severe esophageal gastric varices requiring interventional treatment; (10) Objective evidence showing severe impaired pulmonary function such as pulmonary fibrosis; (11) Any significant clinical and laboratory abnormalities that the investigator considers affecting safety assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescence imaging effect of the live; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of surgery;Intraoperative bleeding;Conversion to laparotomy;Duration of hepatic parenchymal transection;Number of hemostatic clips used on the liver transection surface;Tumor margins;Postoperative complications;Postoperative hepatic function;Postoperative bowel function recovery time;Postoperative hospital stay; | — |
Countries
China
Contacts
Public ContactHong Wu
West China Hospital, Sichuan University
Outcome results
None listed