The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

NCT07150624 | Recruiting Phase 4

• 1 other identifier: CXPJJH125002-2503
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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 hepatectomy for hepatocellular carcinoma were compared.

Conditions

Hepatocellular Carcinoma (HCC); Liver Diseases

Outcome Measures

Primary Outcomes (1)

• The average change of ALT on the 5th day after the operation

  The 5th day after the operation

Secondary Outcomes (5)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Experimental Group

control group

ACTIVE COMPARATOR

Drug: control group

Interventions

Experimental Group 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.

Experimental group

control group DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• The Second Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Lianxin Liu

CONTACT

0551-96512; liulx@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 2, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)