The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

NCT ID: NCT07150624

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2026-03-31

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC); Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: DRUG

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.

control group

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: DRUG

Receiving 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation.

Interventions

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.

Intervention Type: DRUG

control group

Receiving 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lianxin Liu

Role: CONTACT

liulx@ustc.edu.cn

0551-96512

Facility Contacts

Lianxin LIU L LIU

Role: primary

liulx@ustc.edu.cn

0551-96512

Other Identifiers

CXPJJH125002-2503

Identifier Type: -

Identifier Source: org_study_id