The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

Official title

Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study

Overview

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 hepatectomy for hepatocellular carcinoma were compared.

Interventions

• Drug Experimental Group
  Receiving 930mg of polyene phosphatidylcholine injection one day before the operation,twice a day. And 930mg of 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.
• Drug control group
  Receiving 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation.

Primary outcome measures

• The average change of ALT on the 5th day after the operation [Time frame: The 5th day after the operation]

Secondary outcome measures (5)

• The average change of ALT on the 1th day after the operation [Time frame: The 1th day after the operation]
• The average change of ALT on the 3th day after the operation [Time frame: The 3th day after the operation]
• The rate of ALT returning to normal on the 5th day after the operation [Time frame: The 5th day after the operation]
• The rate of AST returning to normal on the 5th day after the operation [Time frame: The 5th day after the operation]
• AEs [Time frame: Observation period 5 days after the operation]

Eligibility criteria

Inclusion criteria

• Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.
• Surgical scope (defined by randomization stratification):Stratum 1: Major hepatectomy, involving the resection of at least 3 Couinaud liver segments, including right hemihepatectomy and extended right hemihepatectomy, etc.Stratum 2: Minor hepatectomy, involving the resection of no more than 2 Couinaud liver segments. This includes right posterior sectorectomy, right anterior sectorectomy, left lateral sectionectomy, single segmentectomy, etc.
• During the operation, the Pringle method is used to block the first hepatic portal. Each block lasts ≤ 15 minutes, and the blocking procedure is performed 2 to 4 times.
• Age: 18 - 80 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 < 10%, and the residual liver volume/standard liver volume > 40%.
• A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system.
• Preoperative ALT < 2x ULN (upper limit of normal).
• No history of portal vein embolization prior to enrollment. If TACE treatment was previously received, it must have been completed > 6 months ago; if systemic anti-tumor drug therapy was previously received, it must have been completed > 4 weeks ago.
• No liver-damaging treatment drugs were used within two weeks prior to enrollment.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Anhui Provincial Hospital — Hefei

Identifiers

NCT: NCT07150624 · CXPJJH125002-2503

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗