The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

University of Science and Technology of China (USTC)

Status and phase: Enrolling; Phase 4

Conditions: Hepatocellular Carcinoma (HCC); Liver Diseases

Treatments: Drug: control group; Drug: Experimental Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07150624

CXPJJH125002-2503

Details and patient eligibility

About

A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hemihepatectomy for hepatocellular carcinoma were compared.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection
2. Those who plan to undergo right or left hemi-liver resection
3. During the operation, the Pringle method was used to block the first hepatic portal. Each block lasted for no more than 15 minutes, and the blocking procedure was performed 2 to 4 times.
4. Age: 18 - 70 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m2
5. Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III
6. Preoperative ICG R15 was less than 10%, and the residual liver volume was more than 40% of the standard liver volume
7. A single HCC (hepatocellular carcinoma), with a tumor diameter less than 10 cm, without distant metastasis or invasion of the portal vein system
8. Preoperative ALT was less than 2 times the upper limit of normal
9. Before being enrolled in the study, the patient had no history of any other treatments, such as portal vein embolization, TACE or systemic anti-tumor drug therapy.
10. No liver-damaging treatment drugs were used within two weeks prior to enrollment.

Exclusion criteria

1. Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc
2. Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds)
3. Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses
4. During the operation, microwave treatment or a combination of microwave treatment was adopted
5. More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes
6. Non-anatomic liver resection, where the remaining liver contains large areas of ischemic/edematous regions
7. More than 1000ml of blood transfusion during the operation
8. During the operation, an extra-hepatic disease was discovered. Other organs except the gallbladder needed to be removed simultaneously
9. During the operation, other intrahepatic lesions were discovered, which required combination with other surgeries, such as ablation or choledochojejunostomy
10. Diseases that have previously received systemic treatment with glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system-related disorders
11. Psychosis, severe neurosis, those who cannot cooperate with this experiment
12. Participated in other clinical trials within the previous 3 months before enrollment
13. Allergy or intolerance to benzoic acid, or to the study drug
14. Pregnant and lactating women
15. The researchers believe that any participants who have any other factors that would make them unsuitable for this trial should not be included

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Drug: Experimental Group

control group

Active Comparator group

Treatment:

Drug: control group