The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy 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 hepatectomy for hepatocellular carcinoma were compared.

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: Experimental Group; Drug: control group

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lianxin Liu; Phone Number: 0551-96512; Email: liulx@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Provincial Hospital
      • Contact: Lianxin LIU L LIU; Phone Number: 0551-96512; Email: liulx@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.
2. 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.
3. 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.
4. Age: 18 - 80 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 < 10%, and the residual liver volume/standard liver volume > 40%.
7. A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system.
8. Preoperative ALT < 2x ULN (upper limit of normal).
9. 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.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Drug: control group; Receiving 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation.
Experimental: Experimental group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The average change of ALT on the 5th day after the operation	The 5th day after the operation

Secondary Outcome Measures

Outcome Measure	Time Frame
The average change of ALT on the 1th day after the operation	The 1th day after the operation
The average change of ALT on the 3th day after the operation	The 3th day after the operation
The rate of ALT returning to normal on the 5th day after the operation	The 5th day after the operation
The rate of AST returning to normal on the 5th day after the operation	The 5th day after the operation
AEs	Observation period 5 days after the operation

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Collaborators: The First Affiliated Hospital of Anhui Medical University; The Second Hospital of Anhui Medical University; First Affiliated Hospital of Wannan Medical College; The First Affiliated Hospital of Bengbu Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: August 28, 2025
• First Posted (Actual): September 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Liver Diseases; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: CXPJJH125002-2503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No