Malnourished patients with liver cirrhosis and liver cancer
Conditions
Interventions
Sponsors
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Hepatectomy cirrhotic patients with BCLC stage A and B of liver cancer; 2.Liver function is Child-pugh Score A; 3.Age between 18-75 years (inclusively), male and female adults; 4.NRS-2002 score >=3; 5.Expected to require TPN or SPN for at least 5 days; 6.Agreed to participate in the study with signed informed consent form by patient or legal representative.
Exclusion criteria
Exclusion criteria: 1. Surgery cannot completely remove the lesion; 2. Accept tumor ablation, repeat hepatic hilar occlusion; 3. BCLC stage C and D; 5. Severe renal insufficiency, including any of the following: (1) Serum creatinine > 4 mg/dL (or 353.6 µmol/L); (2) Long-term peritoneal dialysis or hemodialysis; 6. Severe acquired or congenital hypertriglyceridemia: triglyceride >=3 mmol/L (or 267 mg/dl); 7. Receive TPN for 3 consecutive days within 1 week before the start of the study; 8. Received chemotherapy or radiotherapy within 1 month before the start of this study; 9. Severe chronic neurological disease, such as cerebrovascular accident and persistent neurological deficit within the past 6 months; 10. The patients participated in other interventional clinical studies within 4 weeks before the start of this study, and did not simultaneously participate in drug trials during the study period to 30 days (last follow-up); 11. Medical history showing known hypersensitivity to fish, egg, soy or peanut protein or any active substance or excipient of the study drug; 12. According to the judgment of the investigator, patients who are not eligible to participate in this study, such as pregnant or lactating patients, patients with acute pulmonary edema, patients with decompensated cardiac insufficiency or patients with congestive heart failure; 13. The patient is pregnant or breastfeeding and intends to continue breastfeeding; 14. The patient has severe coagulation disorder or acute shock; 15. Intraoperative/postoperative disease progression (assessed postoperatively and before patient enrollment): (1) Intraoperative blood transfusion volume > 1000 ml; (2) Occurrence of conditions with contraindications to PN; (3) Intraoperative or postoperative urine output < 0.5 mL/kg/h; (4) Postoperative hemofiltration or dialysis is required; (5) Contraindication or inability to intubate through the central vein; (6) Serious intraoperative complications, including resuscitation, hemorrhagic and septic shock, acute single-organ and multiple-organ dysfunction, including prohibition of early postoperative intubation due to pulmonary, hepatic, and renal insufficiency, and the need to accept liver Specific therapy and renal replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of LTB5 from Day 1 ( baseline before drug infusion )to day 6; Change of IL-6 from Day 1 ( baseline before drug infusion )to day 6; | — |
Secondary
| Measure | Time frame |
|---|---|
| The length of hospital stay after hepatectomy.; Immune-related factors: Change of IgA, IgM, IgG, complement C3 and C4 from day 1 ( baseline before drug infusion ) to day 6;Infection - free days;Antibiotics - free days;Area under curve (Linear up log down trapezoidal method) of IL-6 from Day 1 to treatment day 6;Other inflammatory response indicators: changes in CRP, IL-1, IL-10, TNF-a from day 1 (baseline before drug infusion) to day 6; | — |
Countries
China
Contacts
Public ContactZhang Biixiang
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed