Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hemihepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study
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.
• Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection
• Those who plan to undergo right or left hemi-liver resection
• 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.
• Age: 18 - 70 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m2
• Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III
• Preoperative ICG R15 was less than 10%, and the residual liver volume was more than 40% of the standard liver volume
• A single HCC (hepatocellular carcinoma), with a tumor diameter less than 10 cm, without distant metastasis or invasion of the portal vein system
• Preoperative ALT was less than 2 times the upper limit of normal
• 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.
⁃ No liver-damaging treatment drugs were used within two weeks prior to enrollment.