Status:
RECRUITING
The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine
Lead Sponsor:
Anhui Provincial Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Anhui Medical University
The Second Hospital of Anhui Medical University
Conditions:
Hepatocellular Carcinoma (HCC)
Liver Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 da...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07150624
Start Date
August 30 2025
End Date
March 31 2026
Last Update
September 2 2025
Active Locations (1)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000